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vol. NO. 52 Issue NO. 05 (Pages: 45) 01 to 07 february 2021 ISSN 0970-6054 weekly publication
Indian APIs & Formulations for Global Healthcare
union Budget 2021-22: Highlights (Page No. 4)
IDMAIDMA Submission and BDMAI on Draft joint Guidelines Submission for dealing on Environmental cases Approvalsof discontinuation – regarding of Scheduled Bulk Formulations Drug Industry (Page No. (Page4) No. 32) ‘Why Phytopharmaceutical Drug Discovery?’ by Dr S S Handa MoEF(Page No. 6)amendment brings APIs and intermediates under single category (Page No. 37) Advisory: COVID-19 – Amendments/Relaxations/Compliances DCG(I)(Page No. 8) calls for suggestions from industry to reduce complianceExport restrictions burden on Hydroxychloroquine (Page No. 37) lifted (Page No. 19) IDMA Bulletin DoP LII (05)comes 01 to 07 out February with 2021 draft Guidelines for Rs.6,940 crore PLI scheme1 Union Budget 2021-22: Vaccine-focus a shot in the arm (Pageto promote No. 39) domestic production of Bulk Drugs (Page No. 32)
IDMA Bulletin LII (05) 01 to 07 February 2021 2
Founder Editor: Vol. No. 52 Issue No. 05 01 to 07 February 2021 Dr A Patani Editor: IDMA ACTIVITIES: Dr Gopakumar G Nair Associate Editors: J L Sipahimalani Union Budget 2021-22: Highlights...... 4 Dr Nagaraj Rao Dr George Patani National President Direct Tax Highlights-Finance Budget 2021-22...... 18 Mahesh H Doshi Immediate Past National President Pharma sector reacts to Union Budget 2021-22...... 25 Deepnath Roy Chowdhury Senior Vice-President Dr Viranchi Shah IDMA and BDMAI joint Submission on Environmental Vice-Presidents: Bharat N. Shah Approvals – regarding Bulk Drug Industry...... 32 (Western Region) Asheesh Roy (Eastern Region) IDMA Members donate Medicines to Shanti B K Gupta Avedna Sadan for the Care of the Advanced and (Northern Region) T Ravichandiran Terminally ill Cancer Patients...... 33 (Southern Region) Hon General Secretary New Developments: Dr George Patani Hon Joint Secretaries J Jayaseelan Drugs, vaccines less effective vs new virus variants Atul J Shah Hon Treasurer antibody cocktail may protect patients’ contacts...... 34 Vasudev Kataria For information contact IDMA Secretariat: (H.O.) Researchers trying tapeworm, vertigo and Daara B Patel Secretary-General pancreatitis drugs to fight COVID-19...... 35 T R Gopalakrishnan Deputy Secretary-General Melvin Rodrigues National News: Sr Manager (Commercial & Administration) C K S Chettiar Covid shadow on Budget 2021: Health gets a Asst. Manager (Publications & Administration) Delhi Office: vaccine shot, water in new ‘well-being’ category ...... 36 Ashok Kumar Madan Executive Director S Ranganathan DCG(I) calls for suggestions from industry to reduce Asst Manager (Administration) compliance burden...... 37 IDMA STATE BOARDs CHAIRMAN Gujarat State Board : Milan Patel Haryana State Board : P K Gupta MoEF amendment brings APIs and intermediates Himachal Pradesh & under single category...... 37 Uttarakhand State Board : R C Juneja Karnataka State Board : S M Mudda Madhya Pradesh State Board : Paresh Chawla Covid blessing? Finally, biotech gets booster shot...... 38 Tamil Nadu, Puducherry & Kerala State Board : J Jayaseelan Telangana State Board : Shaik Janimiya Union Budget 2021-22: Vaccine-focus West Bengal State Board : Shiv Sagar Tewari A Publication of a shot in the arm...... 39 Indian Drug Manufacturers' Association 102-B, 'A-Wing', Poonam Chambers, Dr. A.B. Road, Worli, Mumbai - 400 018 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 IDMA & Aptar joint webinar on e-mail: mail_ [email protected]/ “Accelerating [email protected]/ Website: www.idma-assn.org and De-Risking Your Product Development”: Published on 7th, 14th, 21st and 30th of every month Announcement...... 41 Annual Subscription ` 1000/- (for IDMA members) ` 2000/- (for Government Research/Educational Institutions) IDMA Bullein Advt. Tariff Card...... 42 ` 4000/- (for non-members) US$ 400 (Overseas) Please send your payment in favour of Indian Drug Manufacturers' Association Advertisements...... 2, 40, 43, 44 & 45 IDMAOpinions Bulletin Expressed LIIXLIV By Th(05)e Au(38) t01ho rs08 to Of to07 Individu 14 February Octoberal Articl 2021e s2013 3 Do Not Necessarily Represent The Official View Of Idma.
IDMA ACTIVITIES Union Budget 2021-22: Highlights Resilience in face of Once in a Century Crisis
Confirmed Cases
Doubling time
Deaths
V Shaped Recovery
GDP Growth
IIP Inflation (%)
IDMA Bulletin LII (05) 01 to 07 February 2021 4
Atma Nirbhar Bharat Abhiyan
Stimulus provided under ANB out of total stimulus 9%
Stimulus by Govt and RBI combined 15%
GOVERNMENT REFORMS ENERGY . Increase in borrowing limits of state o Liquidity support for governments discoms . Privatisation of Public Sector o Elimination of Regulatory Enterprise Assets o Commercial coal mining MSMEs AND INDUSTRY o Reduction in cross- Collateral free loans for businesses subsidy Fund of funds will be set up for MSMEs SOCIAL SECTOR PM Garib Kalyan Yojana National Digital Subordinate debt for MSMEs Health Blueprint Disallowing global tenders of up to Additional Allocation Rs 200 crore for MGNREGS Change in definition of MSMEs Technology driven education: PM eVidya, National MIGRANT WORKERS Foundational Literacy One Nation One Card and Numeracy Free food grain Supply to migrants Mission
AGRICULTURE AND ALLIED SECTORS . Concessional Credit Boost to farmers . Agri Infrastructure Fund . Emergency working capital for farmers . Animal Husbandry infrastructure development . Amendments to the Essential Commodities Act . Agriculture marketing reforms
IDMA Bulletin LII (05) 01 to 07 February 2021 5
Holistic Approach to Health
Preventive Supplementary Nutrition Programme and Poshan Abhiyan to be merged and Approach launched as Mission Poshan 2.0
Curative Wellbeing
Outlay ₹64180 crore over 6 years Support for Health and Wellness centres
PM Setting up of Integrated Public AtmaNirbhar Health Labs Swasth Establishing critical care Bharat Yojana hospital blocks
Strengthening NCDC Expanding integrated health information portal
• Pnuemococcal vaccine to be rolled across the country • ₹35000 crore for Covid-19 Vaccine in 2021-22 Health Outlay (₹ crore)
2021-22 BE 223846
2020-21 BE 94452
Introduction of National Commission for Allied Healthcare Professionals Bill
IDMA Bulletin LII (05) 01 to 07 February 2021 6
Industry
PLI launched to create manufacturing global champions across 13 sectors with amount committed nearly ₹1.97 lakh crore in next 5 years starting FY2021-22
NIP projects by sector 120 Sector wise share in GVA Energy Road Urban Railways Others 100
24% 80 29%
60
18% 40 12%
17% 20
0 2014-15 2015-16 2016-17 2017-18 2018-19 2019-20 2020-21 NIP Project pipeline expanded to 3rd RE 2nd RE 1st RE 1st AE 7400 projects Agriculture, forestry & fishing Industry Services
MITRA Scheme to create world class infrastructure for global champions in textile sector leading to creation of 7 textile parks over 3 years.
Infrastructure
Road Construction Per Day in km National Rail Plan • Aims at developing adequate rail infrastructure by 2030 to cater to the projected traffic requirements up to 2050. • The objective is to increase the modal share of rail in freight from the current level of 27 per cent to 45 per cent.
IDMA Bulletin LII (05) 01 to 07 February 2021 7
• 100% electrification of Broad Gauge Routes by 2023 • Indigenously developed automatic train protection system to be launched
139 GW of installed capacity was added during 6 years Installed Plant connecting additional 2.8 crore households with addition Capacity (GW) of 1.41 lakh circuit km of transmission lines 400 350 300 Revamped reforms-based result-linked power distribution 250 sector scheme will be launched with an outlay of 200 ₹3,05,984 crore over 5 years 150 100 Hydrogen energy mission will be launched 50 0 2013-14 2019-20 Ports, Shipping, Waterways
PPP mode to be utilised Recycling of Ships Act, Subsidy support to for managing 2019 enacted and promote flagging of operational services of recycling capacity to be merchant ships major ports doubled by 2024
Logistics Performance Index Rank PNG Infra financing
54 Ujjwala scheme to cover 1 crore more Bill to set up a DFI beneficiaries will be introduced
100 more districts National monetisation under city gas pipeline of brownfield distribution network infra assets
44 Independent gas transport system 2014 2018 operator to be set up
IDMA Bulletin LII (05) 01 to 07 February 2021 8
Urban Development Jal Jeevan Mission (Urban) for universal water supply in all ULBs
Urban Swachh Bharat Mission with outlay ₹1,41,678 crore over 5 years
₹2,217 crore for 42 urban centres to tackle air pollution
Voluntary Vehicle Scrapping policy
Innovative PPP models to augment public bus transport
MetroLite and MetroNeo for tier 2 and peripherals of tier 1 cities Financial Reforms
Rationalised single Securities Markets Code by 2022 World class fintech hub at GIFT IFSC Permanent institutional framework for Corporate bond market SEBI as regulator and greater role for WDRA for development of commodity market ecosystem Investor charter as a right across all financial products Amending the Insurance Act,1938 to increase the FDI limit with safeguards Asset Reconstruction Company Limited and Asset Management Company to resolve stressed assets problem of PSBs.
IDMA Bulletin LII (05) 01 to 07 February 2021 9
Inclusive Development
AGRICULTURE MSP (crores) 80000 Extending coverage of 160000 SWAMITVA Scheme to all 60000 states/UTs 130000 40000 Expansion of Operation 100000 Green scheme to include 22 20000 perishable products 70000
1000 more mandis to be 40000 0 integrated with e-NAM
FISHERIES MSP Paddy (LHS) MSP Wheat (RHS)
o Development of modern fishing harbours and fish landing centres o Multipurpose Seaweed Park to be set up in Tamil Nadu
MIGRANT WORKERS AND LABOURERS
One nation one ration Share of casual labour in 2018-19 card scheme under implementation in 32 states and UTs. Total A portal to be launched for gig, building and Urban construction workers Social security benefits will be Rural extended to gig and platform workers 0 5 10 15 20 25 30
IDMA Bulletin LII (05) 01 to 07 February 2021 10
Human Capital
EDUCATION SKILLS GII Rank Revamped Post Realigning 90 Matric National Scholarship Apprenticeship 80
Scheme for Training scheme 70 welfare of SCs for graduates and 60 100 new Sainik diploma holders in schools Engineering 50
750 Eklavya Partnership with 40 schools in tribal UAE and Japan in areas area of skill 30 development and 20
recognition 10
0
Accreditation Regulation
R&D Standard setting Funding National Higher Research Education Commission Foundation with of India outlay of ₹50,000 crore over 5 years Expenditure on Education as per cent of GDP National 2020-21 BE 3.5 Language Translation 2019-20 RE 3 Mission to boost 2018-19 2.8 internet access 2017-18 2.8 Deep Ocean
2016-17 2.8 Mission for ocean 2015-16 2.8 exploration and 2014-15 2.8 biodiversity -0.5 0.5 1.5 2.5 3.5 conservation
IDMA Bulletin LII (05) 01 to 07 February 2021 11
Fiscal Position
• Allowing a normal ceiling of net borrowing for the states at 4% of GSDP for 2021-22 1 • Additional Borrowing ceiling of 0.5% of GSDP subject to conditions
2 NSSF loan to FCI for food subsidy to be replaced by making budget provisions
3 ₹1,18,452 crore as Revenue Deficit grant to 17 states in 2021-22
9.50 10.00 Fiscal Deficit Capital Expenditure 9.00
8.00 6.80 7.00 6.00 4.60 5.00 Percent of GDPof Percent 4.10 3.90 4.00 3.50 3.50 3.40 3.00 2014-15 2015-16 2016-17 2017-18 2018-19 2020-21 RE 2020-21 BE 2021-22 2019-20 Actuals 2019-20
35 External Debt 12
30 10 25 8
20 6 15 Percent Percent GENERAL 4 GOVERNMENT 10 DEBT TO GDP 5 2
0 0 2013 2018 2019 2020
Debt Service Ratio External Debt to GDP Ratio of Short-term debt to reserves2020 (Sept-end)
IDMA Bulletin LII (05) 01 to 07 February 2021 12
Tax proposals
Taxpayers Tax Return Exemption from filing income tax returns for opted for Direct Filers senior citizens (75 years and above) who only Tax Vivad se (crore) have pension and interest income. The paying Vishwas Scheme 7 bank will deduct the necessary tax on their 6 income. 120000.00 5 100000.00 Reducing time limit for reopening of income tax 4 assessment 80000.00 3 60000.00 2 Constitution of a Dispute Resolution Committee for 40000.00 1 small tax payers 0 Income Tax Appellate Tribunal to be made faceless 20000.00 2014 2020 0.00 Increase in limit for tax audit Dividend payment to for persons who carry out 95% REIT/InvIT to be exempted Additional deduction of their transactions digitally from TDS of ₹1.5 lakh shall be available for loans Pre filling of returns will also Eligibility for claiming tax taken up till 31 cover capital gains from listed holiday for start ups March 2022 for securities, dividend income, proposed to be extended by purchase of etc. one more year affordable house
Indirect Tax GST Collection Rationalisation of customs duty 1.4 structure by eliminating outdated 2020-21 2019-20 exemptions 1.2 1.14 1.15 Support to MSMEs hit by recent 1.00 1.00 1.05 1.05 sharp rise in iron and steel prices 1.02 0.98 1.0 0.95 and relief to metal recyclers 1.031.03 Rationalisation of duties on raw 0.87 0.92 0.95 0.8 0.91 0.86 material inputs to man made 0.62 textiles 0.6 Rationalisation of custom duty on
In Rs Lakh In Rs Lakh crore gold and silver 0.4 0.32 Increase in duty on solar invertors and lanterns to promote domestic 0.2 production Agriculture Infrastructure and 0.0 Development Cess on small Apr May Jun Jul Aug Sep Oct Nov Dec number of items
IDMA Bulletin LII (05) 01 to 07 February 2021 13
Rupee comes in
Non Debt Capital Receipts 5% Borrowings and other Liabilities 36% Income Tax 14%
Union Excise Duties 8%
Non Tax Revenue 6% Corporation Tax Customs 13% 3%
GST 15% Rupee goes out
Pensions Other Expenditure 5% Centrally Sponsored 10% Schemes 9%
Central Sector Schemes Subsidies 14% 8%
Defence 8% Finance Commission and Other Transfers 10%
Interest Payments 20% States' Share of Taxes and Duties 16%
IDMA Bulletin LII (05) 01 to 07 February 2021 14
Budget at a Glance
Revenue Receipts (crore) Capital Receipts (crore)
2020926 1895152 1788424 1684059 1694812 1555153
1021304 1002271
2019-20 2020-21 2020-21 2021-22 2019-20 2020-21 2020-21 2021-22 (Actuals) (BE) (RE) (BE) (Actuals) (BE) (RE) (BE)
Revenue Expenditure (crore) Capital Expenditure (crore)
554236 3011142 2929000 2630145 439163
2350604 412085 335726
2019-20 2020-21 2020-21 2021-22 2019-20 2020-21 2020-21 2021-22 (Actuals) (BE) (RE) (BE) (Actuals) (BE) (RE) (BE)
IDMA Bulletin LII (05) 01 to 07 February 2021 15
Allocation to major schemes
MGNREGA (crore) PM KISAN (crore)
111500
2021-22 BE
73000
2020-21 RE
0 10000 20000 30000 40000 50000 60000 70000
2020-21 RE 2021-22 BE National Health Mission (crore) National Education 37500
Mission (crore) 37000
36500 2021-22 BE, 36000 34300 2020-21 RE, 35500 28244 35000
34500 2020-21 RE 2021-22 BE
Jal Jeevan Mission (crore) Metro Projects (crore)
20000 2021-22 BE 2021-22 18000 BE, 16000 18998
2020-21 RE 14000 12000
0 20000 40000 60000 10000 8000 2020-21 6000 RE, AMRUT and Smart Cities (crore) 6484 4000 2021-22 BE 2000 2020-21 RE 0 2020-21 RE 2021-22 BE 0 5000 10000 15000
IDMA Bulletin LII (05) 01 to 07 February 2021 16
Major Allocations
Ministry of Housing and Urban 54581 Affairs
Ministry of Health and Family 73932 Welfare
Ministry of Education 93224
Ministry of Railways 110055
Ministry of Road Transport and 118101 Highways
Ministry of Agriculture and 131531 Farmers' Welfare
Ministry of Rural Development 133690
Ministry of Home Affairs 166547
Ministry of Consumer Affairs, Food 256948 and Public Distribution
Ministry of Defence 478196
0 200000 400000 600000 Rs. Crore
IDMA Bulletin LII (05) 01 to 07 February 2021 17
Direct Tax Highlights-Finance Budget 2021-22
Courtesy: Mr B G Barve, Chairman, IDMA Excise and Taxation Committee CORPORATES provision is also made requiring the adding back Depreciation on goodwill of expenditure related to such dividend income if debited to the profit and loss account. It is proposed that: (This amendment will take effect retrospectively from • The block of asset shall not include goodwill of 01.04.2020) a business or profession and therefore it will not be eligible for depreciation. TAX DEDUCTED AT SOURCE/TAX COLLECTED • Goodwill will be construed as a capital asset AT SOURCE/ADVANCE TAX giving rise to capital gains in case of its sale/ Tax Deduction at Source (TDS) on purchase of transfer. goods • In a case where goodwill of a business or Section 194Q is introduced to levy a TDS of 0.1% profession formed part of a block of asset on on purchase of goods from resident exceeding which depreciation has been claimed until Rs. 50 lakhs during financial year only if the buyer’s Assessment Year 2020-21, the written down total sales/ gross receipts from business exceeds value of that block of asset and short-term Rs. 10 crore during immediately preceding financial capital gains, if any, shall be determined in the year. prescribed manner in the year of transfer of If a transaction is liable to TCS u/s 206C(1H) of the such goodwill. Act, as well as TDS under this section, then as per • In case of goodwill of business or profession second proviso to section 206C(1H) only TDS under acquired by way of purchase and depreciation this section shall be deducted on such transaction. has been claimed, then, the cost of acquisition Hence, now, a payer needs to first check whether of such goodwill will be the purchase price as TDS is deductible under normal provisions of the Act. reduced by the depreciation so claimed until If no, then whether TDS is deductible under this new Assessment Year 2020-21. provision. Again, if no, then the seller would need to collect TCS on the same as per the provisions of Late deposit of employee’s contribution by section 206C(1H). employer to various funds will be disallowed to the employer Further, if the seller, fails to provide his PAN or It is proposed to clarify that the employees’ share Aadhar, provisions of section 206AA would become of various funds will be allowed as a deduction only applicable. However, the rate of TDS in this case has if it is paid on or before the due date mentioned in been amended to be at 5% instead of 20%. the respective Acts and not the due date of filing of (This amendment will take effect from 01st July return of income. 2021) It is also proposed to clarify further that this was TDS/TCS on non-filer at higher rates always the intention of the Act and the reference to due date being the due date of filing of return was It is proposed that any sum or income paid, or incorrectly interpreted. payable, by a person to a person who does not file return of income, the person paying the amount (This amendment will take effect retrospectively from would be liable to deduct TDS u/s 206AB at higher 01.04.2020) of following rates: Relief from applicability of MAT provisions on - twice the rate specified in the Act; or Dividend Income earned by Foreign Companies - twice the rates in force; or It is proposed to extend the above relief from - the rate of 5% applicability of MAT provisions to dividend income (This section shall not apply where the tax is required accruing or arising to a foreign company and credited to be deducted under sections 192, 192A, 194B, to its profit and loss account. Correspondingly, 194BB, 194LBC or 194N of the Act)
IDMA Bulletin LII (05) 01 to 07 February 2021 18
Similarly with respect to TCS, It is proposed that any INDIVIDUAL sum or amount received by a person to a person Taxability of Interest on various funds in case of from a person who is non-filer of income tax return, large contributions: would be liable to collect TCS u/s 206CCA at higher Interest income accrued during the year on the of following rates: employee’s contribution to various provident - twice the rate or rates in force; or funds to the extent attributable to contribution exceeding ` 2.5 lakh in a financial year shall be - the rate of 5% taxable. The non-filer person who has not filed income tax returns for the two immediate previous years in which (This amendment will take effect from 01.04.2021) tax deducted or collected, aggregated to Rs. 50,000 Exemption for Leave Travel Concession Cash or more in each of these two previous years. Scheme (This amendment will take effect from 01st July Under the existing provisions, an employee is eligible 2021) for exemption for travel concession or assistance received from his employer in connection with his [Action to be taken - w.e.f 01st July, 2021, deductor leave to any place in India. will have to collect declaration alongwith copy of last 2 years ITR acknowledgement and Form 26AS from In view of the situation arising out of outbreak of each person whose TDS is to be deducted] COVID pandemic, it is proposed to provide tax exemption for cash allowance in lieu of travel TDS on payments to Foreign Institutional concession subject to the fulfilment of the following Investors (FII) conditions : Income on securities earned by FII shall be subject to TDS at the lower of the following rates: - The employee exercises an option for the deemed LTC fare in lieu of the applicable LTC at the rate of 20%; or, - in the block year 2018-2021; - the rate of income-tax provided in the DTAA - The amount of exemption shall not exceed provided the FII furnishes tax residency certificate Rs. 36,000 per person or 1/3rd of specified Exemption of deduction of tax at source on expenditure, whichever is less; payment of Dividend to business trust in whose . “Specified expenditure” means expenditure hand dividend is exempt incurred by an individual or a member of TDS is not required to be deducted to such income his family during the specified period on credited or paid to a business trust by a special goods or services which are liable to tax at purpose vehicle. an aggregate rate of 12% or above under (This amendment will take effect retrospectively from various GST Laws and goods are purchased 1st April, 2020) or services procured from GST registered vendors/service providers; Advance tax liability on dividend will arise only after declaration/payment of dividend. . “Specified period” means the period commencing from 12th October, 2020 and If the shortfall of advance tax is on account of dividend ending on 31st March, 2021; income earned from domestic companies, the tax-payer will not be liable to pay the interest amount - The payment to GST registered vendor/service on such shortfall provided adequate tax thereon has provider is made by an account payee cheque been paid in the subsequent instalments. It is also or account payee bank draft or ECS and tax provided that the above mentioned concession will invoice is obtained from such vendor or service not extend to deemed dividend. provider; (This amendments will take retrospective effect from - If the amount received by an employee from his 01.04.2020) employer, in relation to himself and his family, Dividend payment to REIT/ InvIT will be exempt for the LTC is more than what is allowable to from TDS such person, the exemption would be available
IDMA Bulletin LII (05) 01 to 07 February 2021 19
only to the extent of exemption admissible under Addressing mismatch in taxation of income from above listed provisions. overseas retirement (This amendments will apply retrospectively from Presently, there is a mismatch in the year of taxability 01.04.2020) of withdrawal from overseas retirement funds by residents who had opened such fund when they were Rationalisation of taxation of Unit Linked non-resident in India and resident in foreign country. Insurance Plan (ULIP) At present the withdrawal from such funds may be Restricted Tax exemption for maturity proceeds of taxed on receipt basis in such foreign countries, while the ULIP having annual premium up to Rs. 2.5 lakh. on accrual basis in India. However, the amount received on death shall In order to address this mismatch, it is proposed continue to remain exempt without any limit on the that the income of a specified person from annual premium. The cap of ` 2.5 lakh on the annual specified account shall be taxed in the manner premium of ULIP shall be applicable only for the and in the year as prescribed by the Central policies taken on or after 01.02.2021. Further, in Government order to provide parity, the non-exempt ULIP shall be provided same concessional capital gains taxation Equalisation Levy - An anamoly removed regime as available to the mutual fund. The exemption section 10(50) is amended which will now apply to e-commerce supply or services Relief to senior citizen (75 years and above) provided ‘on or after April 1, 2020’. Consequently, having only pension and interest income from for FY 20-21 also, in cases where Equalisation Levy pension bank account are exempted from filing is leviable, income tax won’t be leviable. income tax returns. However, the paying bank will deduct the necessary tax on their income. Equalisation Levy on “ROYALTY” or “FEES FOR TECHNICAL SERVICES” – Not Leviable Tax incentive of affordable rental housing project for migrant workers extended till 31.03.2022 for 100% Where there is an overlap between application of deduction of profits u/s 80-IBA. EL and application of income-tax on either royalty or fees for technical services, then, the relevant income Incentives of deduction in respect of interest, up will be taxed as royalty or fees for technical services to Rs. 1.50 lakhs, on housing loans in respect of residential house property having stamp duty value either under the Act or under the relevant tax treaty; not exceeding threshold of Rs. 45 lakhs, has been and Such income will not be subject to EL st extended to loans sanctioned till 31 March 2022. Equalisation Levy – Meaning of “ONLINE SALE Tax incentives u/s 80-IAC for entrepreneurs OF GOODS” and “ONLINE PROVISION OF embarking on new journeys of setting up their own SERVICES” start-ups and Sec 54GB of the Income tax act This aspect is now sought to be clarified by insertion exemption on transfer of residential property for of new Explanation to S. 164 which states that the investment in start-ups taken place are extended till expressions “online sale of goods” and “online 31st March 2022. provision of service” shall include one or more of the Government to notify rules to eliminate double tax following online activities: for NRIs on foreign retirement funds (a) Acceptance of offer for sale; or New section 2(29A) is inserted to define the term (b) Placing of purchase order; or “liable to tax” (c) Acceptance of purchase order; or It means that there is a liability to tax on such person “under any law for the time being in force” in any (d) Payment of consideration; or country and will include a case where subsequent (e) Supply of goods or provision of services, partly to imposition of such tax liability, an exemption has or wholly. been provided. New Definition – “CONSIDERATION RECEIVED st (This amendment will take effect from 1 April, OR RECEIVABLE FROM E-COMMERCE SUPPLY 2020) OR SERVICES”
IDMA Bulletin LII (05) 01 to 07 February 2021 20
It is now proposed to insert a new definition of the Procedure for Assessments, Appeals and other expression “consideration received or receivable from Resolution Mechanism e-commerce supply or services”. This expression Pre-filled income tax return will have pre-filled shall include: data regarding details of capital gains from listed - Consideration for sale of goods irrespective of securities, dividend income, and interest from banks, whether the e-commerce operator owns the post office, etc. goods; Due date for filing of belated and revised ITR - Consideration for provision of services preponed irrespective of whether service is provided or Due date for filing of belated and revised ITR to facilitated by the e-commerce operator. be reduced by 3 months before the end of the relevant assessment year i.e.31st December of CHARITABLE INSTITUTIONS that assessment year or before completion of the Rationalisation to eliminate possibility of double assessment, whichever is earlier deduction by charitable institutions Reduction of time limit for assessment Where the corpus fund has been exempted and its proceedings application has been claimed as application against the mandatory 85% application of non-corpus income Particulars Existing Time Proposed Time results into unintended double deduction. Limits Limits To ensure that there is no double counting while Time limit One year from the Nine months from calculating application or accumulation, it has been for sending end of the FY in the end of the FY proposed that: intimation which the return is in which the return • Voluntary contributions made with a specific u/s.143(1) furnished. is furnished. direction, that it shall form part of the corpus shall be invested or deposited in specified investments Time limit Six months from Three months from maintained specifically for such corpus. for issuance the end of the FY the end of the FY of notice in which the return in which the return • Utilisation of funds out of corpus shall not be u/s.143(2) is furnished. is furnished. considered as application of income for charitable or religious purposes. Time limit Twenty-one Nine months from • However, when amounts are re-invested or for passing months from the the end of the re-deposited in specified investments maintained Assessment end of the AY in AY in which the specifically for such corpus out of the income, Order u/s. which income was income was first then, such amount shall be allowed as application 143(3) or 144 first assessable. assessable. in the previous year in which it is re-deposited to (This amendment will take effect from 01.04.2021) corpus fund. Allowing prescribed authority to issue notice Similarly, it is also proposed that funds applied/ under section 142(1)(i) utilised out of loans and borrowings shall not be considered as application for charitable or religious It is proposed to empower the prescribed purposes. However, when loan or borrowing is income-tax authority besides the Assessing Officer repaid from the income, then, such repayment to issue notice under the said clause. shall be allowed as application in the previous Reassessment & Search Proceedings year in which it is repaid to the extent of such The provisions relating to reassessment and repayment. search assessments are proposed to be completely The blanket exemption for Educational Trusts and substituted as under: limit has been increased from Rs. 1 crore hospitals • Provisions of Section 153A and Section 153C to to (Sec 10(23C)) Rs. 5 crore be applicable only on search initiated u/s 132 or (This amendment will take effect from 1st April, requisition made u/s 132A on or before March 2021) 31, 2021.
IDMA Bulletin LII (05) 01 to 07 February 2021 21
• Common new procedure to be followed in case of ii. If AO has in his possession evidence, that income assessments, reassessments or re- computations chargeable to tax, represented in the form of an in search initiated u/s 132 or requisition made asset, which has escaped assessment amounts u/s.132A after March 31, 2021 which are prescribed to or is likely to amount to Rs.50,00,000/- or in substituted Section 147,148,148A of the Act. more for that year, then ten years from the end • Section 147 to allow AO to assess/reassess or of the relevant AY. re-compute any income escaping assessment in • Section 151 is proposed to substituted to define the any AY. “specified authority” for the purpose of section 148 • Notice under substituted section 148 to be and 148A to mean as under issued before assessment/reassessment/ TIME PERIOD DESIGNATION OF OFFICER re- computation when the AO has “information” that income chargeable to tax has escaped If less than 3 Principal Commissioner or Principal assessment and after following procedure years Director or Commissioner or Director specified in proposed section 148A of the Act. If more than 3 Principal Chief Commissioner or • “Information” which suggests that income is said years Principal Director General or Chief to have escaped assessment has been defined Commissioner or Director General to mean: • Under the proposed amendments, once assessment/ i. Information flagged by a computer reassessment/re-computation has started the AO based system in accordance with the is empowered to assess/reassess the income in risk management strategy formulated by respect of any issue which has escaped assessment CBDT. and which comes to his notice subsequently in the course of proceedings under this procedure ii. Final objection raised by CAG to the effect notwithstanding that the procedure prescribed in that assessment/reassessment has not section 148A was not followed before issuing such been in accordance with the provisions of notice for such income. the Act. (This amendment will take retrospective effect from iii. In case of search, survey, requisition or 01.04.2020) seizure after on or after April 1, 2021, the AO shall be deemed to have information Due date for ITR filing for partners of a firm liable which suggests that income has escaped for Transfer Pricing Audit extended assessment for 3 AY’s prior to year of Due date for ITR filing for partners of a firm liable for search, seizure survey or requisition. Transfer Pricing Audit is being proposed to extend • Section 148A to be inserted to empower the AO to 30th November of the assessment year, since the to conduct inquires, if required, with prior approval total income of such partner can be determined only of specified authority and give the Assessee an after the books of accounts of such firm have been opportunity of being heard before issuance of notice finalised. u/s.148 and after obtaining due approval of “specified Dispute resolution committee for small taxpayers authority”. After considering the Assessee’s reply, with total income less than Rs.50 lakhs and the AO shall decide by passing an order whether it disputed income less than `10 lakhs can approach is a fit case for issuance of notice u/s 148 and serve the committee which is faceless. a copy of such order along with the notice to the assessee. Aforementioned procedure of conducting Establishment of National Faceless Income Tax - All communication shall enquiry, providing opportunity and passing order Appellate Tribunal Centre be electronic. Where personal hearing is needed, it before issuing notice u/s 148 not applicable in search shall be done through video-conferencing. cases. • Time limit for issuance of notice u/s.148: Discontinuation of Income-tax Settlement Commission (ITSC) with effect from 01st February i. Normally, three years from the end of the 2021 and to constitute Interim Board of settlement relevant AY; for pending cases
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Re-opening of assessments on account of Rationalisation of the provision of presumptive income escaping assessment taxation for professionals under section 44ADA It is being clarified that the presumptive taxation Escapement of Proposed Time Limit for scheme for professionals under Sec 44ADA, is Income Liable to Tax Issuing Re-opening Notice applicable only to an individual, HUF or partnership Escaped income up to Within 3 years of the end of firm, however so not including LLP since an LLP is Rs. 50 lakhs the assessment year required to maintain books of accounts in any case Escaped income more Within 10 years of the end of under LLP Act. than Rs. 50 lakhs the assessment year (This amendment will take effect from 01.04.2020) • The Income-tax Officer shall be empowered to Rationalisation of provision of slump sale assess/re-assessor re-compute any income escaping It is proposed to amend the scope of the definition assessment for any assessment year (called relevant of the term `slump sale` so that all types of assessment year). But only after seeking approval transfer defined in the Act are included within its of the Principal Commissioner or Principal Chief scope. Commissioner or Principal Director General. Provision of transfer of capital asset to partner • Before initiating action, a notice shall be required to on dissolution or reconstitution of a firm be issued under section 148 of the Act, which can be issued only when there is information with the It is proposed to tax the firm under the head capital Assessing officer which suggests that the income gains for the amount paid to the partner at the time liable to tax has escaped assessment for the relevant of retirement or dissolution or reconstitution of the assessment year. firm in excess of the balance in the partner’s capital account (excluding balance arising out of re-valuation • Any information which has been flagged in the of assets or self-generated assets). Department’s computer based system in accordance with the risk management strategy formulated by the It is further provided that in computing capital gains Board shall be considered as `information`. in the hands of the firm: • The amount of money paid to the partner and • Before issuance of the notice, the Income-tax Officer the fair market value of assets distributed to shall conduct enquiries, if required, and provide an the partner shall be deemed to be the sale opportunity of being heard to the tax-payer and after consideration. considering his reply, decide by passing an order, whether it is a fit case for issue of notice under section • The cost shall be the balance in the capital 148 of the Act. account of the partner (excluding balance arising out of re-valuation of assets or • Once the assessment/reasses s m e n t o r self-generated assets) in the books of accounts re-computation has been initiated, the Income-tax of the firm at the time of its dissolution or Officer is empowered to take into account any other reconstitution. income which comes to his notice subsequently during the course of such proceedings. Provisional attachment in Fake Invoice cases It is proposed to enable the Assessing Officer to Others exercise the powers under this section during the No Tax Audit for and assessee carrying on business pendency of proceedings for imposition of penalty having turnover upto Rs.10 crores provided 95% of of the Act on such person who makes a false the transactions are carried digitally i.e. cash receipts entry or omit an entry from his books of accounts, during the year does not exceed 5% of total receipts; if the amount or aggregate of amounts of penalty and cash payments during the year does not exceed imposable is likely to exceed ` 2 Crores. 5% of total payments Notified Infrastructure Debt Funds will be eligible (This amendment will take retrospective effect from to raise funds by issuing tax efficient Zero Coupon 1st April, 2020) Bonds.
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Note on GST amendments in Budget 2021-22 Courtesy: Mr B G Barve, Chairman, IDMA Excise and Taxation Committee
Mrs Nirmala Sitharaman presented Union Budget 2021 and manner in which every registered person, other in Parliament on Monday, February 1st, 2021. Presenting than an Input Service Distributor, a person paying the first ever digital Union Budget, she stated that India’s tax under section 51 or section 52, a casual taxable fight against COVID-19 continues into 2021 and that this person and a non-resident taxable person shall moment in history, when the political, economic, and furnish an annual return. strategic relations in the post-COVID world are changing, 5. interest on delayed payment of tax Section 50 is the dawn of a new era – one in which India is well-poised (r.w.e.f 01.07.2017) - Section 50 of the CGST Act to truly be the land of promise and hope. is proposed to be amended, retrospectively, to substitute the proviso to sub-section (1) so as to We have analysed in detail the changes proposed charge interest on net cash liability with effect from under the GST Law – Section wise for easy digest and the 1st July, 2017. implementation when notified. 6. Determination of tax not paid or short paid or A new clause 1. Scope of Supply (r.w.e.f. 01.07.2017): erroneously refunded or input tax credit wrongly (aa) in sub-section (1) of Section 7 of the CGST Act availed or utilised by reason of fraud or any willful is proposed to be inserted, retrospectively with effect misstatement or suppression of facts: Section st from the 1 July, 2017, so as to ensure levy of tax on 74 of the CGST Act is proposed to be amended activities or transactions involving supply of goods or so as make seizure and confiscation of goods and services by any person, other than an individual, to conveyances in transit a separate proceeding from its members or constituents or vice-versa, for cash, recovery of tax. deferred payment or other valuable consideration. 7. amendment in Section 75: An explanation to 2. eligibility and conditions for taking input tax sub-section (12) of section 75 of the CGST Act is credit: A new clause (aa) to sub-section (2) of the proposed to be inserted to clarify that “self-assessed section 16 of the CGST Act is proposed to be inserted tax” shall include the tax payable in respect of to provide that input tax credit on invoice or debit note outward supplies, the details of which have been may be availed only when the details of such invoice furnished under section 37, but not included in the or debit note have been furnished by the supplier in return furnished under section 39. the statement of outward supplies and such details have been communicated to the recipient of such 8. provisional attachment to protect revenue in invoice or debit note. certain cases: Section 83 of the CGST Act is proposed to be amended so as to provide that 3. audit by Chartered Accountant: Sub-section (5) provisional attachment shall remain valid for the entire of section 35 of the CGST Act is proposed to be period starting from the initiation of any proceeding omitted so as to remove the mandatory requirement under Chapter XII, Chapter XIV or Chapter XV till the of getting annual accounts audited and reconciliation expiry of a period of one year from the date of order statement submitted by specified professional. made thereunder. 4. annual return: Section 44 of the CGST Act is Substituting sub-section (1) thereof, which proposed to be substituted so as to remove the empowers the Central Government to provide by mandatory requirement of furnishing a reconciliation rules the manner in which the Commissioner may statement duly audited by specified professional attach provisionally any property, including bank and to provide for filing of the annual return on account, belonging to the taxable person or any self certification basis. It further provides for the person specified in sub-section (1 A) of section Commissioner to exempt a class of taxpayers from 122. the requirement of filing the annual return. 9. appeals to Appellate Authority (Section 107) - A Proposed to empower the Central Government to proviso to sub-section (6) of section 107 of the CGST provide by rules the time within which and the form Act is proposed to be inserted to provide that no
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appeal shall be filed against an order made under confiscation of goods or conveyances and levy of sub-section (3) of section 129, unless a sum equal penalty from the proceedings under section 129 to twenty-five percent of penalty has been paid by relating to detention, seizure and release of goods the appellant. and conveyances in transit. 10. Detention, seizure and release of goods and 12. power to collect statistics. - Section 151 of the conveyances in transit (Section 129) - Section CGST Act is proposed to be substituted to empower 129 of the CGST Act is proposed to be amended to the jurisdictional Commissioner to call for information delink the proceedings under that section relating from any person relating to any matter dealt with in to detention, seizure and release of goods and connection with the Act. conveyances in transit, from the proceedings under 13. bar on disclosure of information (Section 152) section 130 relating to confiscation of goods or - Section 152 of the CGST Act is proposed to be conveyances and levy of penalty. amended so as to provide that no information Sub-section (6) of the said section seeks to empower obtained under sections 150 and 151 shall be used the Central Government to provide by rules the for the purposes of any proceedings under the Act manner in which and the time within which the goods without giving an opportunity of being heard to the or conveyance detained or seized under that section person concerned. shall be sold or disposed of. 14. Paragraph 7 of Schedule II to the CGST Act 11. confiscation of goods or conveyances and Consequent to the amendment in section 7 of the levy of penalty (Section 130) - Section 130 of the CGST Act paragraph 7 of Schedule II to the CGST CGST Act is proposed to be amended to delink Act is being omitted retrospectively, with effect from the proceedings under that section relating to the 1st July, 2017.
Pharma sector reacts to Union Budget 2021-22
Adopting the paperless culture, the Finance Minister surprises that has buoyed overall sentiment. Healthcare Nirmala Sitharaman presented the Union Budget and well-being has received top priority in this budget, 2021-22 which is considered as a well balanced with more than doubling of the outlay to Rs. 223,846 budget. With a considerable focus on healthcare the crore, including the allocation of Rs. 35,400 crore towards government’s intention in driving the investment in COVID-19 vaccination and Rs. 64,184 Cr for a new advancements in biotechnology, smart medicines, scheme to strengthen the country’s primary, secondary virtual and augmented reality, AI & IoT in healthcare and tertiary health infrastructure. are likely to gain momentum. Although the Union Budget 2021-22 recorded higher budget allocation for Other positives include the higher spending on COVID-19 vaccine, but the industry’s expectations of infrastructure, the push for bank privatisation, increased increased weighted deduction on R&D upto 200 percent were absent in the announcement. Therefore, the funding for strengthening the public sector R&D and industry experts have expressed that if the government innovation ecosystem, as well, as increasing the FDI cap could have waived off some taxes on the input material, in insurance from 49 per cent to 74 per cent. Monetisation its result would have cheered by consumer (patient) of public sector assets including land is an important policy directly as medicines would have become more plan which must be implemented expeditiously to support affordable. Besides this, the industry is overwhelmed the mega infra projects. with the government’s recognition of the Health Sector as a First pillar amongst six pillars ‘Healthcare allocation as percentage of GDP dismal; many good measures’ - Sharad Tyagi, President, ‘Overall, a reassuring Budget with no negative OPPI: surprises’ - Kiran Mazumdar Shaw, Executive The Organisation of Pharmaceutical Producers of Chairperson, Biocon: India (OPPI) welcomes the Finance Minister’s proposal Overall, a reassuring budget with no negative to increase the Budget outlay for healthcare marginally
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from last year’s revised estimates of Rs. 69,234 crore boost investment in infrastructure and fuel economic to Rs. 71,269 crore. It is also a welcome step that growth. Rs. 35,000 crores is allocated for COVID-19 vaccine and the assurance that any additional spending required would The significant increase in allocation for health and be allocated for vaccines. well-being augurs well for the nation and can be a driving force and strong foundation for accelerating essential It has been the demand of the healthcare and drugs and health-related consciousness to the last mile of pharmaceutical sectors to increase the public spending Indians. The allocation of funds for COVID-19 vaccination on healthcare from the below one per cent of GDP level will fast track the inoculation drive and it is worth lauding to at least 2.5 per cent of GDP. OPPI is glad to note the the Government’s commitment to provide further funds if Rs. 64,180 crore PM Atma Nirbhar Swasth Bharat deemed necessary. Yojana over six years to develop capacities of primary, secondary, and tertiary healthcare systems, strengthen The budget addresses the gaps in rural and urban existing institutions, new institutions, and focus on healthcare that the pandemic exposed with the ‘PM detection and cure of new diseases. Atmanirbhar Swasth Bharat Yojana’ in addition to the National Health Mission. Along with the emphasis on OPPI also welcomes the support to rural and nutrition, clean water, and clean environment, this will urban health and wellness centers, public health labs, bolster health infrastructure and reach across India. The strengthening the National Centre for Disease Control pharma industry is ready to contribute towards fortifying the (NCDC, connecting the Integrated Health Information health of the nation that is the cornerstone of development. Portal to public health labs, setting up new public health JBCPL stands by the nation! units at the borders and in the country, setting up emergency operation centers, bio-safety laboratories and ‘We are encouraged with Government’s renewed regional virology centres. focus on preventive and curative health’– Rehan A Khan, Managing Director - India Region, MSD: OPPI also welcomes the proposal to amend the “We welcome the much-deserved attention on India’s Insurance Act, 1938 to increase the permissible FDI limit healthcare sector in the Union Budget 2021, and are in insurance sector from 49 per cent to 74 per cent to glad to hear the increase in the total budget outlay for allow foreign ownership and control with safeguards. This healthcare in this year. We are encouraged with the would help global health insurance companies to have Government’s renewed focus on preventive and curative a focused interest in the country. However, it has been health as well as the overall wellness and well-being of disappointing that the Finance Minister has not specifically our citizens .The introduction of the Aatmanirbhar Health laid out any modalities to improve bio-pharmaceutical Yojana in addition to the National health Mission, along research. OPPI hopes the five-year outlay of Rs 50,000 with other announcements in the healthcare and pharma crores to strengthen the overall research ecosystem and sector- such as setting up health and wellness centres, to identify national-priority thrust areas would have a focused approach to improve bio-pharmaceutical research integrated public health labs in each district, – are aimed at in the country. widening access to health and wellness while driving focus on preventive health. These patient centered initiatives will ‘A well-rounded holistic budget’ – Nikhil Chopra, play a pivotal role in the success of the National Health CEO and Whole Time Director, JB Chemicals & Mission. Pharmaceuticals: Healthcare in India is at the cusp of transformation. The “A well-rounded holistic budget that embraces all advancements in biotechnology, smart medicines, virtual sectors through various measures to boost economic and augmented reality, AI & IoT in healthcare are likely to activity. Against the backdrop of the pandemic and gain momentum. This calls for a patient-focused healthcare an economy facing an unprecedented contraction, ecosystem wherein community health, mental health and the Finance Minister has met the challenge face-on other such critical areas are properly represented. The with a budget that has a long term vision laid out in a Government’s focus on self-reliance, especially with the strategic road map. The emphasis on an ‘Aatmanirbhar attention on scaling production capabilities of vaccines and Bharat’ with an increase in capital expenditure will other medicines, demonstrates its commitment to build a
IDMA Bulletin LII (05) 01 to 07 February 2021 26 healthy India. While 2020 has accelerated the foundation It’s encouraging to note the creation of 9 Bio Safety Lab for a digital transformation and innovation of the healthcare (BSL) in the Budget, that will boost research and scientific system, 2021 will support in further widening access and discoveries. increasing digital inclusion in the remotest corners of the country. ‘PM Atmanirbhar Swasth Bharat Yojna will boost healthcare infrastructure across primary, secondary Having said this, there is a need to further bolster and tertiary care’– Sudarshan Jain, Secretary the research and innovation ecosystem in the country General, Indian Pharmaceutical Alliance: in order to ensure that Indian patients receive new The FY22 Budget is in line to support recovery of Indian treatments and cures. An increased collaboration between economy while keeping the overall policy stability and stakeholders from industry, academia, governments, fiscal discipline in perspective. The COVID-19 pandemic non-governmental organisations (NGOs), regulators and is an unprecedented time and has brought importance to patients’ organisations is essential to promote a robust healthcare in India. The focus on healthcare infrastructure research framework which recognises and rewards innovation.” in FY22 Budget is a positive step towards growth with a 137 per cent increase in allocation to the sector at Rs ‘It is a far-reaching budget announcement’ – 2,23,846 crore. The allocation of Rs 64k Cr (over 6 years) Dr Krishna Ella, Chairman and Managing Director, on the PM Atmanirbhar Swasth Bharat Yojna will help boost Bharat Biotech: the healthcare infrastructure across primary, secondary and tertiary care and the Vaccination programme is “It’s a great step ahead, and far-reaching budget well-funded with over Rs 35k, it will help the country announcement, providing `35,000 crore for COVID-19 address the pandemic. All these initiatives are pointers vaccination in 2021-22. The Finance Minister commitment to increased investment in healthcare infrastructure and providing more funds in order to contain the Coronavirus will strengthen the sector going forward. pandemic spread in the country and provide an effective, smooth path for the vaccination scheme will help contain, ‘Union Budget 2021 is positive for Healthcare and lead our nation towards accomplishing a covid-19 Industry’- S V Veerramani, Past National President disease free Bharat. – IDMA & Chairman and Managing Director, Fourrts India Laboratories The lay out plan of a `64,180 crore spending plan for healthcare over the next six years to be spent on The announcement of Rs 64000 Cr for Atmanirbhar primary, secondary and tertiary healthcare, in addition Health scheme is a welcome. As per the Finance to the National Health Mission is also a welcome move, Minister, the healthcare infrastructure fund will also be which will strengthen public health services as 17,000 increased from Rs 94,000 crores to Rs 2,23,846 crores. rural and 11,000 urban health and wellness centres and Besides this, the already announced PLI scheme by integrated public health labs to be set up in each district. the Government together with the proposed funding The government focus, on three areas – preventive for COVID-19 vaccine and Pneumococcal vaccine health, curative health and well-being, is also very augurs well for the healthcare industry in general. reassuring. Our expectations of increased weighted Suchitra Ella, Joint Managing Director, Bharat deduction on R&D upto 200 percent is absent in the Biotech announcement.
The new health infra schemes with significantly higher ‘A big gift to healthcare sector‘- B R Sikri, Vice outlay of Rs 35,000 crore for Bharat’s mega COVID-19 President, BDMA and Chairman FOPE vaccination drive is a huge fiscal medicine to contain the pandemic, reduce disease burden for the population, and We welcome step of the Government for presenting the economy. A record total outlay of Rs 2,23,846 crore for Budget through Digital route i.e. paperless budget. Finance health and wellbeing aimed to boost the health and well- Minister presented her budget speech in six pillars and being of the nation, is also a well-thought announcement in we are grateful to her as health sector was taken as the this budget, with focus on preventive, and curative health. First pillar.
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Scientific efforts to produce two domestic vaccines This year’s budget by the Finance Minister is for COVID not only for India rather than to supply to 100 pragmatic, positive and committed to the healthcare sector countries are remarkable achievements. Rs. 35000 crores which needed a deliberate boost post unprecedented allocated for vaccination of COVID is a welcome step by virus outbreak last year. The announcement of centrally the Government of India. Due to serious health sector funded scheme – Aatmanirbhar Health Yojana – with efforts during COVID, minimum deaths have taken place an outlay of Rs. 64,180 crore over six years in addition in India when compared with other countries seeing size of to National Health Mission is a welcome step towards the population. Seriousness on the part of the Government strengthening primary, secondary and tertiary healthcare towards the health sector itself proves because the in the country. government has increased the health budget from Rs.94 thousand crores to 2.23 Lakh Crores. As an Setting up of 15 Health Emergency Centres shows Industry, we appreciate this great initiative taken by the the government’s intent to be future-ready to address Finance Minister in the Union Budget. any healthcare crises. It is commendable that the government has put healthcare on the forefront, putting Particularly, from the pharmaceutical industry’s point focus on curative and preventive health and wellbeing. The of view, we were hoping that the government will come allocation this year is likely to be around Rs. 2,23,846 crore forward to give some special relief for R&D and rationality of which is a whopping over 130 per cent rise from the budget import duty was also expected. Similarly if the government last year. The proposals would make quality healthcare has waived off some taxes on the input material, it would accessible and affordable, besides standardizing have given not only relief to the pharma industry rather healthcare infrastructure across the country. to the consumers too because the medicines would have become more affordable for a common man. ‘GoI is placing importance on the sector spurred by the COVID pandemic‘ – Rohitashwa Prasad, Partner, ‘This is one of the most challenging budget’- Vivek J Sagar Associates: Padgaonkar, Independent Healthcare Consultant “For FY 21 GoI had budgeted Rs. 69,000 crore for Former-Director OPPI ( Project and Policy), Former healthcare, which was 1.6 per cent of GDP. The budgeted GSK (Sales and Marketing): amount for FY 22 shows a significant increase. If this Global economy is in a very difficult phase in the last growth were to be extrapolated, the GoI should achieve fifty years and India can be no exception to this so perhaps the target of healthcare spend of 2.5 – 3 per cent of GDP this is one of the most challenging budget for our Finance (as envisaged in the National Health Policy 2017) well minister Nirmala Sitharaman. before its target date. This is quite promising and clearly illustrates the importance that the GoI is placing on the At the back drop of shrinkage of the economy by sector spurred by the COVID pandemic. 24% in the first quarter of 2020, due to global pandemic, the Union Budget proposal 2021-22 rests on six different What is also very commendable is that the GoI has pillars. The inclusion of Health and wellbeing, innovation allocated Rs.35,000 crore for the COVID-19 vaccine and R&D, and the budget allocation increased by as a separate line time. This shows that the GoI has 137 per cent over the previous year, will have a significant avoided the pitfall of focusing all its resources on tackling contribution for the Indian life science sector. communicable diseases at the cost of building healthcare systems generally because of the COVID-19 pandemic, The ‘PM Atmanirbhar Swasth Bharat Yojana‘ which which notwithstanding its materially adverse impact on the will be launched with a total outlay of Rs. 64,180 crore health and economy, is an extraordinary event. The GoI over a period of next six years, with a focus on developing has thus avoided the saliency bias which the Economic capacities of healthcare systems, develop institutions for Survey had warned against. detection and cure of new and emerging diseases will boost Indian pharma industry. ‘Budget 2021 is realistic, positive, and holistic’ – Akshay Daftary, Director, SIRO Clinpharm: ‘This year’s budget is pragmatic, positive and committed to the healthcare sector’ – Harshit Jain “In this year’s budget, the Finance Minister considered MD, CEO and Founder, Doceree: the health and well-being sector as the first pillar, which
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is very encouraging for healthcare and nutraceuticals just five states now and also from the currently available sector professionals. The announcements made by two vaccines, there would be two more vaccines which the FM especially for the healthcare sector in terms of can be approved soon. promised reforms and anticipated conducive measures to boost domestic manufacturing of the medical devices Healthcare got the much needed boost by strengthening along with the emphasis on preventive care, PPP in the expenditure increase and also by expanding Virology Ayushman Bharat, expansion of Jan Aushadhi Kendra in institutes. The launch of PM Aatmanirbhar Swasth Bharat all districts to provide medicines at affordable rates, Yojna includes multiple priorities from supporting the etc. are very promising and will provide impetus to the Health and Wellness Centres, setting up critical care growth of the sector in the long run. The allotment of hospital blocks, strengthening of primary, secondary and Rs. 3000 crore funds under skill development is a tertiary healthcare centres. positive move by the government in terms of recruiting people since the EMS (Emergency Medical Services) As from the word of the Finance Minister “Three industry demands skilled individuals in paramedics as areas - preventive health, curative health and well-being they are the ones driving the sector and hence play a to be strengthened during the current year fits well into vital role in saving lives. the budget for this space.
The allocation of Rs. 35,000 crore for COVID-19 ‘An increase by 137 per cent in the budget outlays vaccines was much needed as it is the need of the shows that the Government is serious’ - Sushant hour. Additionally, the allocation of Rs. 69,000 crore Raorane, Director and Co-founder Adroit Biomed: to healthcare is again something that is commendable An increase by 137 per cent in the budget outlays and a heartening measure announced by the FM for the shows that the Government is serious. Just the symbolic development of the healthcare sector. Overall, Budget placement of the sector in the first section of the budget 2021 is realistic, positive, and holistic at the same time, speech shows the government’s commitment to enhance centered around the common man and his needs.” the health infrastructure for the wellness of all citizens. There is going to be a special thrust in natural medicines ‘Launch of PM Aatmanirbhar Swasth Bharat Yojna and therapy and this will give a boost to the nutraceutical includes multiple priorities’ – Dr Hari Natarajan segment. We welcome this budget for sure and aim to work Founder and Dr Karishma Shah, Director, Pronto hard for a self-confident and self-reliant India. Consult: The first budget of the new decade saw the necessary ‘Aatmanirbhar Swastha Bharat Yojana have hit the boost required for Healthcare and India as a whole taking bullseye’ – Sidharrth Shankar, Partner, J Sagar care of most of the stakeholders is the budget for New Associates: India. The experiences of COVID-19 have delineated the importance for emerging economies to invest in healthcare The health sector has got a 2.24 L crore allocation and infrastructure at all levels – primary, secondary and the increase in spending is as per the expectations of the tertiary. The budgetary announcements of the outlay healthcare sector, which as per the Finance Minister is a of Rs. 64,180 crore under the Aatmanirbhar Swastha 137 per cent increase over last year. Bharat Yojana have hit the bulls eye in this area. The approach followed by the Indian government is a The infusion of capital into multiple projects across marked departure from existing practices of reduction of transportation, railways, public service would help to out-of-pocket expenditure of the citizens. give the necessary boost for employment generation and would facilitate the increase in money flow into the ‘First time, the government has explicitly mentioned economy and would give a boost to the economy. the emphasis on overall wellbeing’- Sanjaya Mariwala, Executive Chairman and Managing Director, Omni GoI has also provided Rs 35400 crore for COVID-19 Active Health Technologies and Founder President vaccination in 21-22 and also the pneumococcal vaccine, of the Association of Herbal and Nutraceuticals Made in India product would be rolled across India from Manufacturers of India (AHNM):
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“Focus on both preventive and curative healthcare provision of Rs.35,000 crores for COVID-19 vaccine and in the Nutrition Programme 2.0 is a great boost for the focus on disease control and surveillance will help cope nutraceutical industry. For the first time, the government with the immediate needs brought forth by the pandemic, has explicitly mentioned the emphasis on overall wellbeing. the setting up of National Institutes for virology and Mission Poshan 2.0, which will be focused on strengthening Integrated Health Labs, an updated Health Information nutritional content, delivery, and the outcome is a great portal will all prepare us for future such eventualities. initiative and a big boost for the nutraceutical industry. The pandemic had brought to the fore the stark Further extension of the PLI scheme and emphasis on shortage in infrastructure and medical and paramedical manufacturing in India is also encouraging. We will look medical resources. The budget announced setting up and forward to further specifics especially the PLI scheme for upgradation of primary, secondary and tertiary health units the nutraceutical sector. across districts and blocks as well as a focus on allied healthcare professionals and that is a welcome step. ‘The budget proposals reflect an embolden India’- Chintan Gandhi, Managing Director – Millennium What seems to be missing was the support and boost Herbal Care: that was expected to encourage private investment in healthcare infrastructure as well in manufacture of medical The budget proposals reflect an embolden India, devices. There was also no mention of specific support possibly buoyed by the government’s overall handling and incentives for R&D and innovation for Pharma and of the pandemic relative to other countries. The ability to Medical technology. comfortably budget the deficit at 6.8 per cent is the need of the hour. In reference to the healthcare sector, just the It was the private sector that really rose to the symbolic placement of the sector in the first section of the challenge during the last year whether it was on innovation budget speech shows the government’s commitment to or manufacture of drugs, devices and vaccines or on enhance the health infrastructure for the wellness of all testing and treatment and it was expected that it will be citizens. This shall be good for the Ayurvedic sector too, provided a boost.” especially with the recent appreciation from consumers. The budget is definitely aimed to make India a better ‘The government did not meet the industry’s place to do business’-Sumit Kumar, Vice President expectations of taxation’ - Parvathavardhini – NETAP, TeamLease: Natarajan, Associate Director, Ratings, Brickwork Ratings: The budget is definitely aimed to make India a better place to do business, to work for a common man and On the taxation side, the government did not meet the expectations of the industry which looked forward to tax to massify quality education. The increased focus and benefits on R&D investments in pharma and lower GST impetus on infrastructure, manufacturing, financial sector for life-saving drugs. and health sector will create employment opportunities which makes the case stronger for the skilling ecosystem ‘No mention of specific support and incentives to ensure productivity at execution. Skilling will step up in for R&D and innovation’ - Charu Sehgal, Partner the automotive sector at both ground level for production and Leader, Lifesciences and Healthcare, Deloitte and also at the macro level to boost R&D and prepare the India: workforce for Industrial Revolution 4.0. ”The budget 2021 has provided the much expected increase in public expenditure on Healthcare. The FM has The outlook to amend the Apprenticeship Act will lead announced an outlay of Rs. 64,180 crores over six years to attractive incentives for small and Medium Enterprises, though, on Atma Nirbhar Swasthya Bharat scheme in especially in the auto ancillary segment and will further addition to the National Health Mission budget. boost skilling through apprenticeships along with the OEMs which further creates employment opportunities. There appears to be an integrated approach whereby both the short term and immediate needs as well as the Realignment of National Apprenticeship Training longer term measures have been proposed. While the Scheme (NATS) and the allocation of Rs 3000 crores will
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motivate organisations for providing apprenticeship training. to improve and fill gaps in the primary, secondary, and Commencing degree and diploma apprenticeships in the tertiary health segments. The hope is that this will make non-technical stream will improve the employability factor a measurable difference to the access and delivery of high for the youth and prepare a productive workforce in the quality healthcare for all. country. However, India’s health challenges are huge and Additionally, the setting up of The Higher Education require a high degree of collaboration between the public Commission will help us understand the ground realities and private health sectors to improve healthcare access, of execution of policies like that of the National Education Policy among other education reforms, and will help in increase insurance cover, bring down out of pocket addressing challenges in execution as well. However, expenses and ensure a good supply of new innovative the budget’s silence on the regulatory front especially drugs. The Indian pharmaceutical industry needs strong for Skills Universities and relaxation of laws in online incentive to invest in making India a pharma research hub education licensing is a bit disappointing as these aspects for the country and the world. are very crucial for improving affordability, accessibility and scalability of quality education in India. ‘Higher allocation to the MSME industry’ – Mahendra Patel, Managing Director, Lincoln ‘Overall it is an ambitious budget’ – Suresh Pattathil, Pharmaceuticals: MD, Allergan India: Budget is in line to help recovery of Indian economy Overall, this is an ambitious, growth-oriented budget post COVID-19 while keeping taxation neutral, policy and the FM has tried to ensure that the economy receives stability and fiscal discipline in perspective. Higher the impetus it needs to go back to a respectable GDP allocation to the MSME industry and 137 per cent rise in growth level. We are glad that in line with the vision of allocation to the health sector will further boost the health ‘Atmanirbhar Bharat‘, the FY22 budget identifies six pillars infrastructure in the country. Overall it is a good budget on which to build a future ready India. We are particularly with higher allocation to infrastructure, agriculture which glad that health and wellbeing and innovation and R&D are need of the hour. are included here. (With inputs from Viveka Roychowdhury and Lakshmipriya The significant increase in budgetary support for the Nair) health sector is most welcome. The additional outlay of Rs. 64,180 crore over the next six years is to be spent Source: Express Pharma, 02.02.2021
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have you renewed your membership for the years 2019-2020 & 2020-2021 if not, please do so; kindly contact IDMA Secretariat at: Email: [email protected] / [email protected] Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723
IDMA Bulletin LII (05) 01 to 07 February 2021 31
IDMA ACTIVITIES IDMA and BDMAI joint Submission on Environmental Approvals – regarding Bulk Drug Industry
IDMA and BDMAI have made a joint submission with no immediate relief at the ground level to majority of on 1sr February 2021 to Shri Rameshwar Prasad API manufacturers. Gupta, IAS, Secretary, Ministry of Environment, Forest & Climate Change (MoEFCC), New Delhi with Further, the OM is silent on issue of “removal copy to Ms S Aparna, IAS, Secretary, Department of of cap on Production quantity”. It was agreed as per Pharmaceuticals, Ministry of Chemicals & Fertilizers, Minutes against Issue-1 (see below) that only the New Delhi as below: quantity and quality of effluent (pollution load) need to be regulated. "We thank you for the MoEF&CC Office Memorandum F.No.22-33/2019-IA.III dated 28.01.2021, confirming future Decision: The Secretary, EF&CC has agreed appraisals of all proposals for Environmental clearance in-principle and directed to initiate amendment in EIA under provisions of EIA Notification 2006 and subsequent Notification, 2006 regarding permitting the change amendments under the category of the schedule of EIA in product mix or raw material mix including no cap Notification 2006 for the “API and Intermediates“ as on increase in the production quantity without prior single category instead of individual products. (The Office environmental clearance as long as there is ‘no increase Memorandum is published in IDMA Bulletin issue dated in pollution load’……… 30 January 2021 - page no.17) We assume that this will be covered in soon to be announced comprehensive amendment to EIA Notification This was a long pending request of Pharma Industry 2006, if not we request that a separate OM be issued on and it is a very welcome step in the right direction, this subject. which will help accelerate growth of API industry. While the notification refers to only “Prior Environmental Some other issues were also discussed in this Clearance….and subsequent amendments”, it is silent meeting regarding change of “Product Mix” for which as to how currently valid/under renewal EC/ CTE / CTO we hope similar OMs are in the offing. As regards the mentioning individual products can be converted into simplification of application forms for ToR and EC, we single category documents. There are also no specific have already shared our suggestions with Secretary, guidelines for SPCBs to this effect. As the wording stands, Pharmaceuticals and hope the same must have been only a handful of new (greenfield) units, and those whose forwarded to you by now. We look forward to a meaningful EC is up for amendment will get benefit of this notification discussion on the same with your officials at their earliest while omitting most of the existing units with valid EC/CTE convenience. /CTO. Thus, our request for a corrigendum to this OM laying down simple procedure for existing / under renewal We once again thank you very much for your kind ECs / CTEs / CTOs for amendment from existing individual acceptance of our proposals for simplification of operating product names to a single category. Unless this is done, procedures without effecting the cause of environmental all the good intentions of MoEF will remain just on paper protection."
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IDMA Members donate Medicines to Shanti Avedna Sadan for the Care of the Advanced and Terminally ill Cancer Patients
IDMA, Lions Club of Byculla along with the Sisters and Patients at Shanti Avedna Sadan humbly thank our IDMA Members mentioned below for their generous contribution of medicines to Shanti Avedna Sadan:
1. Ajanta Pharma Ltd
2. Alkem Laboratories Ltd
3. Cachet Pharmaceuticals Pvt Ltd
4. Cipla Ltd
5. Galpha Laboratories Ltd
IDMA along with a few Lions (number restricted 6. Intas Pharmaceuticals Ltd due to Covid-19 Pandemic) of Lions Club of Byculla on 26th January 2021 completed their annual contribution 7. IPCA Laboratories Ltd of medicines to Shanti Avedna Sadan, on a home for 8. Micro Labs Ltd the continuing care of the Advanced and Terminally ill Cancer Patients located at Bandra (W), Mumbai.
Shanti Avedna Sadan is India’s first Hospice, an Institution that takes care of the advanced terminally ill Cancer patients. It is neither a hospital nor a home, but is in fact both, offering the specialized care of a hospital together with the love of a home.
IDMA & Lions Club of Byculla had started this tradition of contributing medicines required by Shanti Avedna Sadan every year for the past several years and we are grateful and thankful to our IDMA Members for contributing every year for this noble cause. l l l
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New Developments
Drugs, vaccines less effective vs new REGEN-COV, containing the drugs casirivimab and virus variants antibody cocktail may imdevimab, has so far caused a 100% reduction in symptomatic infection and roughly 50% lower overall rates of protect patients’ contacts infection, the company announced on Tuesday, 26.01.2021. The following is a roundup of some of the latest The results suggest that the cocktail may not only reduce scientific studies on the novel coronavirus and efforts to transmission of the virus but may also reduce disease severity find treatments and vaccines for COVID-19, the illness in those who get infected, said Regeneron research chief and caused by the virus. co-founder George Yancopoulos. The therapy, which would be given to those in close contact with an infected person, Coronavirus variants escape effects of antibody drugs: immediately delivers virus-fighting antibodies into the body Antibody therapies and vaccines for treating or as opposed to vaccines spur the body’s immune system preventing COVID-19 are likely to be less effective against to develop its own antibodies over weeks. “This approach some of the new variants of the coronavirus circulating could protect patients receiving chemotherapy for cancer, around the world, a new study suggests. Of particular enable control/prevention of outbreaks in an institutional concern is the variant identified in South Africa and another setting and reduce pressure on health services,” said one first found in Brazil with similar features. In lab tests, Dr Penny Ward from King’s College London. The initial Eli Lilly and Co’s antibody bamlanivimab was inactive data comes from the first 409 subjects of a trial that hopes against the South Africa strain, according to a report posted to recruit 2,450 participants. Full data from the trial are on Tuesday, 26.01.2021 on bioRxiv ahead of peer review. expected in April. The drug just last week had shown an ability to cut the risk of COVID-19 by 80% for nursing home residents. The Blood cancer drug shows promise against COVID-19: activity of one antibody in Regeneron Pharmaceuticals A drug used in Australia to treat blood cancer might be Inc’s dual-antibody therapy was impaired by the South a powerful treatment for COVID-19, new research suggests. Africa variant, although the cocktail remained potent. And The drug, plitidepsin - also known as aplidin - acts against tests of blood from people who got either of the COVID-19 a protein in cells the virus uses to replicate. In test tube vaccines from Pfizer Inc or Moderna Inc showed antibodies experiments with human lung cells, plitidepsin was generated by the shots were less effective against the South 27.5 - fold more potent than Gilead Sciences Inc’s Africa variant, although Moderna has said it still believes remdesivir at inhibiting the virus, researchers reported on its vaccine will provide protection. Monday, 25.01.2021 in Science. “Mutationally, this virus is traveling in a direction that In mice with COVID-19, the drug produced a could ultimately lead to escape from our current therapeutic 99% reduction of viral loads in the lungs and reduced and prophylactic interventions,” the researchers said. “If inflammation.Researchers have begun testing the drug in the rampant spread of the virus continues and more critical humans with COVID-19 and are working with regulatory mutations accumulate, then we may be condemned to agencies on plans for larger trials. Rather than targeting a chasing after the evolving SARS-CoV-2 continually, as we protein in the virus, as many drugs do, plitidepsin targets have long done for influenza virus.” Lilly and Regeneron a protein in patients’ cells. This means that if the drug said this week that they are working on new versions of proves successful in humans, the virus could not easily their drugs to address the new variants. gain resistance through mutation.
Antibody cocktail may protect patients’ household (Open tmsnrt.rs/3c7R3Bl in an external browser for contacts: a Reuters graphic on vaccines in development. Reporting by Nancy Lapid and Christine Soares; Editing by Bill A two-drug antibody cocktail from Regeneron Berkrot) Pharmaceuticals called REGEN-COV prevents Source: Nancy Lapid, Reuters, 28.01.2021 (Excerpts) COVID-19 in people exposed to an infected household member, preliminary data suggest. In an ongoing study, l l l
IDMA Bulletin LII (05) 01 to 07 February 2021 34
Researchers trying tapeworm, vertigo has been used to treat pancreatitis in Japan and Korea. and pancreatitis drugs to fight COVID-19 Nefamostat works by binding to one of the two receptors that allow the COVID-19 spike to enter human cells. Professor The plan to vaccinate the global population against Josh Davis is from the Menzies School of Health Research, COVID-19 is a noble one, but the importance of which is part of the study. “The likelihood is at least one treatment to the affected is of prime importance too or two of the interventions we’re looking at will prove to be KEY HIGHLIGHTS effective,” Professor Davis told ABC. “But we don’t think any • Could the common blood pressure medications, one of these will be a magic bullet.” There are more than 70 called angiotensin receptor blockers, help reduce hospital and trial sites in Australia, India and Denmark. the impact of Coronavirus? Take heart, this medication might work: • Some scientists in Australia are experimenting on nefamostat, an obscure drug that has been used Another major study by The George Institute for Global to treat pancreatitis in Japan and Korea. Health and the University of Sydney is looking at whether • Could inhaling a common cancer drug and anti-viral common blood pressure medications, called angiotensin called interferon help will stop the COVID-19 virus receptor blockers, could help reduce the impact of from infecting people? coronavirus. The new phase four study led by Professor Meg Jardine is looking at common Angiotensin Receptor Vaccines may not be the silver bullet that will end the Blockers (ARBs) like candesartan (Atacand), irbesartan, COVID-19 pandemic, say, researchers. Since most vaccines losartan and telmisartan. It has been found that people aren’t 100 per cent effective, it’s not likely that they will already taking these medications do not get any sicker than fortify the entire community. It will be several months the rest of the population if they get COVID-19. before the majority of the population will be vaccinated and till such day, effective treatments for COVID-19 will Trials on inhalers, cancer drugs: hold the day. Scientists are also carrying out experiments to check While we understand that vaccines are key to prevent if inhaling a common cancer drug and anti-viral called COVID-19 infecting a person’s body, it is treatments that will interferon will stop the COVID-19 virus from infecting help us get better if we do acquire the infection. According people. The premise they are working on is the possibility to a report in the Australian website abc.net.au, the country’s that the medication can block the virus from entering the cells in the nose and upper respiratory tract. A Chinese doctors and patients are at the forefront of global efforts claims that it found the method prevented healthcare to develop those treatments, and a number of treatments workers from catching the virus, but in Australia, lead are under trial. In some critically ill patients, steroids like investigator Professor Monica Slavin warned that study dexamethasone, along with hydrocortisone and prednisolone, was limited. “It wasn’t a really well-conducted study, but have been able to save the lives of patients fighting it’s promising,” she said. Researchers are also looking at COVID-19 in a safe, cheap and widely available protocol. whether a cancer drug called selinexor can help. “It’s the standard of care now,” Infectious diseases Vertigo drug, anti-tapeworm medicine under scanner too: physician Dr James McMahon told. Dr McMahon said some of the drop in case fatality rates globally could also be The drug, called ifenprodil, is being tested by a attributed to health professionals simply getting better at Canadian drug company called Algernon Pharmaceuticals. It was developed in the 1970s and has been used to managing COVID-19. “They’re better at identifying people treat vertigo in Japan. The same report also states that who are becoming unwell. Better at identifying people who South Korean firm Daewoong Pharmaceutical is looking to are vulnerable,” he said. Several existing drugs with well- repurpose an antiparasitic drug that is used to treat patients established safety profiles are the source of inspiration suffering from tapeworms, also known as niclosamide. It’s for some scientists who are now trying to repurpose those been turned into a long-acting injection and it’s hoped it drugs to treat COVID-19. will prevent the virus from invading host cells by inhibiting Japanese pancreatitis drugs: a protein called SKP2. Source: Kirti Pandey, www.timesnownews.com, 26.01.2021 Scientists at the University of Melbourne are experimenting with a hemostat, an obscure drug that l l l
IDMA Bulletin LII (05) 01 to 07 February 2021 35
National News
Covid shadow on Budget 2021: Health Welcoming the allocation, Union Health Minister gets a vaccine shot, water in new Dr Harsh Vardhan said: “The experiences of the country’s yearlong fight with Covid have shaped the Union Budget. ‘well-being’ category This will give a tremendous boost to India’s health With covid infections crossing the 1-crore mark, and infrastructure… Investment on Health Infrastructure in claiming nearly 1.54 lakh lives, the Government has allocated Budget 2021 has increased 2.37 times or 137 per cent. Rs. 64,180 crore in the Union Budget presented Monday, The focus on strengthening three areas — Preventive health, 01.02.2021 to upgrade public health care infrastructure curative health and well-being — with total allocation to the under a new flagship PM AtmaNirbhar Swasth Bharat health sector being Rs. 2,23,846 crore will be of immense initiative over six years — and unveiled a new expenditure help to the country at this critical juncture.” head called “health and well-being”. Sitharaman, meanwhile, emphasised that PM Atma Spelling out medium and long term expenditure for the Nirbhar Swasth Bharat will be implemented in addition public health care system, which came under severe stress to the National Health Mission — and provide “support” during the initial stages of the pandemic, Union Finance for 17,788 rural and 11,024 urban health and wellness Minister Nirmala Sitharaman pegged the total expenditure centres. “This will develop capacities of primary, secondary, for “health and well-being” at Rs 2,23,846 crore — an and tertiary care health systems, strengthen existing increase of 137 per cent — including Rs 35,000 crore for national institutions, and create new institutions to cater immunisation with Covid vaccines. to detection and cure of new and emerging diseases,” she said. The Finance Minister underlined that the Government will take a “holistic approach” this time by strengthening Under the new scheme, five key interventions will be three critical areas: “Preventive health, curative health implemented, specifically catering to new and emerging and well-being.” diseases: integrated public health labs in all districts and 3,382 block units in 11 states; critical care hospital blocks “Even at the outset, I would like to say that the in 602 districts and 12 central institutions; a strengthened investment on health infrastructure in this Budget has National Centre for Disease Control (NCDC) and its five increased substantially. Progressively, as institutions absorb regional branches and 20 metro health surveillance units; more, we shall commit more… the Budget outlay for ‘health and, a national institution for One Health, a regional and well-being’ is 2,23,846 crore in BE (Budget Estimates) research platform for WHO (South East Asia), nine Bio- 2021-22 as against this year’s BE of 94,452 crore, an Safety Level III laboratories and four regional national increase of 137 percentage,” Sitharaman said. institutes for virology. The Rs. 2.23 lakh crore will include expenditure on six The scheme will also provide funds to set up 15 components in varying proportions: Department of Health & emergency operation centres and two mobile hospitals, Family Welfare (31.83 per cent) with finance commission operationalise 17 new public health units and strengthen grant (5.89 per cent); Department of Drinking Water & existing units at the 32 airports, 11 seaports and seven land Sanitation (26.81 per cent) with finance commission crossings. On nutrition, Sitharaman said that to strengthen grant (16.09 per cent); vaccination (15.63 per cent); “content, delivery, outreach, and outcome”, it has been health research (1.89 per cent); Ministry of AYUSH decided to merge the supplementary nutrition programme (1.32 per cent); and, nutrition (1.20 per cent). and Poshan Abhiyan to launch “Mission Poshan 2.0”. “We The allocation shows that drinking water and sanitation shall adopt an intensified strategy to improve nutritional has received the biggest boost of 179 per cent, with funds outcomes across 112 aspirational districts,” she said. for health and family welfare increasing by 9.62 percent Sitharaman said that WHO has “repeatedly” stressed while nutrition witnessed a drop of 27 per cent. Sitharaman the importance of clean water, sanitation and clean said the Centre is “committed to provide further funds if environment “as a prerequisite to achieving universal required” for Covid vaccines and that the pneumococcal health”. “The Jal Jeevan Mission (Urban), will be launched. vaccine, presently limited to only five states, will be rolled It aims at universal water supply in all 4,378 urban local out across the country. bodies with 2.86 crore household tap connections, as
IDMA Bulletin LII (05) 01 to 07 February 2021 36
well as liquid waste management in 500 AMRUT cities. Committees can help in updating the guidelines as is It will be implemented over five years, with an outlay of done in the WHO. Rs. 2,87,000 crore,” she said. Dr Rajesh Gupta, All India Head, Laghu Udyog Source: Kaunain Sheriff M, Indian Express, 02.02.2021 Bharati Pharma Wing and President of Himachal Drug Manufacturers Association, said, “To ensure ease of doing l l l business modules, we need to amend various sections of DCG(I) calls for suggestions from D&C Act 1940, which was discussed by all associations like IDMA, FOPE, BDMA, HDMA, CIPI. During the industry to reduce compliance burden presentation, we demanded that instead of suspension Pharma associations are likely to submit their and licences cancellation on prima-facia, there should recommendations by early next month be a consideration for an improvement period and show The Drug Controller General of India (DCGI) has asked cause notice for compliance to genuine and valid license industry associations to submit their representations manufacturing holders.” highlighting aspects or issues in the Drug and Cosmetics “We have also requested that Section 33 P guidelines Rule 1945 that can be made redundant to reduce the should become a Rule and law should protect genuine compliance burden on the industry. manufacturers and license holders from spurious In a recently held webinar, ‘Reducing Regulatory allegations,” said Gupta. He said that due to misuse of Compliance Burden’, the DCGI interacted with industry Section 17(c) and (D), many genuine and valid license representatives from IDMA, BDMA, FOPE, OPPI, CIPI, holders are being prosecuted. HDMA – Laghu Udyog and asked them to highlight Sudarshan Jain, Secretary-General, Indian regulatory issues faced by the industry. Pharmaceutical Alliance, commented, “We are in the Some of the associations have already submitted their process of preparing a representation requested by the representation, whereas many of them are likely to submit DCGI. In the next few days, we will be able to submit our it by early next month. The IDMA representative requested recommendations to the authority.” that instead of making Schedule M mandatory it should be Dr Viranchi Shah, National Vice President, IDMA, informed, in the form of guidelines. The IPA representative expressed “This is an excellent and apt initiative of the DCGI, Dr Somani. that the implementation of Schedule M should be done Removing the redundant provisions under the D&C Act and at the earliest. rules will greatly enable the updation of the law to the needs of IDMA suggested making separate rules for excipients the current times. The current law is over 75 years old, formed and disinfectants and also pointed out that there is in an era when India imported most of our pharma needs. a need to properly define APIs and NSQs to avoid Today, the scenario has changed, we are global misinterpretation. producers, and therefore the change in Act and Rules is due, The association also highlighted issues pertaining in order to fit the current and future needs of the society. to shelf-life of formulations. It said that in the current This step will also help reduce the burden of compliance scenario, shelf-life of formulations is not allowed to go and help improve the efficiency of the operations of this beyond the shelf-life of APIs. It also stressed that bulk industry. This is a path-breaking initiative with a long term drugs which are exported and returned for reasons of vision and IDMA heartily welcomes it.” non-compliance of physical parameters like moisture, Source: Usha Sharma, Express Pharma, 29.01.2021 particle size and bulk density should be permitted to be sold in the domestic market. It is not allowed currently. l l l Similarly, HDMA and IPA requested for QR codes on APIs. BDMA will be preparing a detailed report to submit MoEF amendment brings APIs and to the regulatory authority on joint inspection for WHO intermediates under single category certification which is taking a long time. The Ministry of Environment, Forest and Climate During the session, the association representatives Change (MoEF) has issued a letter with an amendment that also suggested creating Centre-State Committees clubs APIs and intermediates as a single category instead wherein industry experts can also join. And these of individual products. The move has been appreciated
IDMA Bulletin LII (05) 01 to 07 February 2021 37
by industry stakeholders as it will provide them with the Covid blessing? Finally, biotech flexibility to change the raw material mix/or product mix gets booster shot within the sanctioned pollution load. After years of being ignored by successive FMs, the The Ministry has taken the decision based on the Covid-19 pandemic finally forced the government to take several presentations made by the industry representatives note of the biotech sector that has been leading the fight requesting for issuance of Prior Environmental Clearance under the provisions of EIA notification 2006. against the dreaded Coronavirus. According to issued communication by the MoEF, the FM prescribed several matter has been examined in the Ministry and henceforth all d i r e c t a n d i n d i r e c t the Expert Appraisal Committees of Environment Ministry/ booster doses this year, SEAc (State Expert Appraisal Committee) should appraise including Rs. 35,000 crore the proposal for prior Environmental Clearance under allocation for Covid-19 the provisions of EIA notification 2006 and subsequent vaccination, national rollout amendments under the Environmental Impact Assessment of pneumococcal vaccine (EIA) notification 2006 for APIs and intermediates as a and investments in public single category instead of individual products. research and innovation infrastructure. Pointing out that Accordingly, the EAC/SEAC should recommend the this is the first time the FM has spoken about preventive permissible pollution load i.e.quantity and quality including and curative health and wellbeing, Bharat Biotech CMD the composition of emissions, discharge and solid waste Dr Krishna Ella said the announcements were significant generation from such activity for inclusion in the prior and far-reaching. “FM’s commitment providing more funds Environmental Clearance. to contain the pandemic spread and provide an effective for the vaccination scheme will lead to accomplishing a Mahesh Doshi, National President, IDMA, expressed, “It is a long pending demand from the IDMA. On behalf of the Covid-19 free Bharat,” Ella said. Indian pharma industry, we acknowledge the initiated efforts taken by the DoP Secretary, S Aparna. After understanding the industry’s concerns she ably managed to lead a high delegation from the Ministry of Environment, Foreign and Climate Change and managed to deliberate in favour of the industry. Certainly, this step will help the industry to further flourish the Indian pharma industry’s image in the competitive global pharma market.” B R Sikri, VP, BDMA and Chairman, FOPE, commented, “It is a welcome step. The industry has been pursuing this issue with GoI for several years and it is a very positive step on behalf of the Environment Ministry because it will increase production since within the load sanctioned we will be able to switch over to other product ranges. I wish it would have been done long back but there is a saying “Der aye durust aye,” i.e. better late than never. It will have far-reaching, positive consequences for the nation provided State Pollution Control Boards do not find fault in implementing Serum Institute of India CEO Adar Poonawalla said this great change in the system. Atma Nirbhar Bharat is the emphasis on healthcare spending and immunisation now achievable since the Government’s way of working has will help India recover rapidly from the pandemic and also changed and it has started listening to the industry.” encourage more innovation and expansion. Speaking of Source: Usha Sharma, Express Pharma, 30.01.2021 healthcare infrastructure and vaccines, Poonawalla said: l l l “Investments in these areas have prevented hospitalizations
IDMA Bulletin LII (05) 01 to 07 February 2021 38
and resulted in a healthier and more productive workforce, The budgeted spend for health and family welfare, leading to an efficient economy.” though, is nearly 11% lower than the revised estimates for the current fiscal, at Rs. 71,268 crore versus FY21 Biocom CMD & Association of Biotech Led Enterprises revised estimate (RE) of Rs 78,866 crore — a chunk (ABLE) chairperson Dr Kiran Mazumdar Shaw said while of FY21RE spend, over the FY21 budget estimate (BE) there were several moves to strengthen the public research of Rs. 65,011 crore, could be attributed to emergency and innovation ecosystem, the big missing piece was the response to the Covid-19 pandemic. “The continuing lack of encouragement to private sector R&D. Stating that India has been recognised as being at the epicentre modest allocation towards the healthcare sector would of Covid-19 management, she said: “It’s disappointing make it challenging for the government to meet its the government feels we don’t need R&D incentives and target of public sector healthcare investment of 2.5% should be left to fend for ourselves, but they ought to look of the GDP by 2025,” said Kapil Banga, Assistant Vice at it more seriously.” “Covid-19 has opened their eyes. President, Icra.
The government has moved positively and I am Sitharaman also announced the launch of a new very glad they are trying to strengthen the biotech centrally-sponsored scheme, the PM Atma Nirbhar Swasth manufacturing base, but what about R&D, which is the Bharat Yojana, with an outlay of Rs. 64,180 crore over six legs on which the sector stands? It’s a move forward but the step is too small,” said Shantha Biotechnics founder years. The scheme aims to bolster primary, secondary and K I Varaprasad Reddy. tertiary healthcare in the country and envisages setting up of public health laboratories in all districts and critical Source: The Times of India, 02.02.2021 care hospital blocks in 602 of these. l l l With pandemic/epidemic readiness a big policy Union Budget 2021-22: Vaccine-focus concern, the scheme will also focus on setting up of 15 a shot in the arm health emergency operation centres. Apart from creation of new public health units and strengthening of existing Indian Union Budget 2021-22: Against the backdrop ones at 50 points of entry to India, nine biosafety of the Covid-19 pandemic, Finance Minister Nirmala level (BSL) III labs — India mandates BSL II/III for all Sitharaman announced on 1 February that the Centre was SARS-CoV-2 manipulations, with virus isolation, cell providing Rs. 35,000 crore for vaccination against the culture, and neutralisation assay reserved for BSL III disease. The Budget documents mention a Rs. 33,572 crore labs only — and four National Institutes of Virology will ‘provision of financial assistance to meet expenditure on also be set up. Covid-19 vaccination’ in FY22. While the Serum Institute of India had said earlier this year that it will make 10 crore The announcement has received a mixed response doses of Covishield, one of the two vaccines approved from health-sector experts. “A total allocation of in India, available to the Centre at Rs. 200 per dose, at Rs. 64,180 crore over a period of six years may thinly Rs. 500 for a two-dose-vaccine regime, the provision should spread the resources to many announcements under this cover doses for 67 crore people. programme. However, a beginning has been made in this The government estimates a 30-crore target population direction,” said Sarit Rout, a health economist with the (comprising health and frontline workers, people above Public Health Foundation of India. Ali Mehdi, who leads the age of 50 and people below 50 with co-morbidities) the Health Policy Initiative, however, believes instead of for its priority inoculation drive, while, as per the a new central scheme, the money should have gone to Socio-Economic and Caste Census 2011 data, the states. “The Centre should accept that health is a there were 13.4 crore households in India whose state responsibility and try to strengthen state systems,” highest-earning member had a monthly income of below Mehdi says. Rs. 5,000. Source: Sarthak Ray, Financial Express, 02.02.2021
l l l
IDMA Bulletin LII (05) 01 to 07 February 2021 39
IDMA ACTIVITIES CDSCO MATTERS CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on its Regulatory Members Pathway – reg. DCG(I) Circular Ref.X-11026107/2020-PRO, dated 20th March 2020
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CSR InitiativesHealth CDSCOby Organization IDMA provides with(WHO) has the declared guidancesupport it as pandemic. of on its Regulatory Members Pathwayth – reg. DCG(I) Circular Ref.X-11026107/2020-PRO, dated 20 March 2020 At present there is no current evidence from randomized 5. 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YIDMAear 2019-2020Year 2019-2020 BULLETIN & 2020-2021 & 2020-2021 Sai Seva Mandal: IDMA is thankful to the above membersYear for 2019-2020Ytheirear help 2019-2020 & 2020-2021 & 2020-2021 KIIDMAND ATTENTIO NB OFU ALLLLETIN SUBSCRIBERS OF hospital,” Vishwakarma said. as early as possible as our understanding of COVID-19 If not, pleaseIf donot, so; please kindly do contact so; kindly IDMA contact Secretariat IDMA at: Secretariat at: 1. Alkem Laboratories Ltd. and support. and the tools to combat it evolve. If not, pleaseIf not, do please so; kindly do so; contact kindly IDMA contact Secretariat IDMA Secretariat at: at: Email: [email protected]: [email protected] / [email protected] / [email protected] Email: [email protected]: [email protected] / [email protected] / [email protected] Tel.: Tel.: 022 022 - 2494 - 2494 4624 4624 / 2497/ 2497 4308 4308 / For AdvertisingFor Advertising in the Classified in the Classified Columns Columns and alsoTel.: andfor 022 series also - 2494Tel.: for 4624I 022 NDIANseries /- 24942497 46244308 / D/ 2497 Fax:RUGS 4308022 - 2495/ Fax: 0723 022 - 2495 0723 s !DVANCEHave youFIT FOR PURPOSE renewed your MREGULATORYembership ANDfor the LIABILITYTel.: 022 Tel.:- 2494 022 4624 - 2494 / 2497 4624 4308 / 2497 / Fax: 4308 022 / - Fax:2495 022 0723 - 2495 0723 Fax:Fax: 022 022 - 2495 - 2495 0723/ 0723/ Have you renewed your for the advertisementsadvertisements please contact: please contact:We are pleased to state that INDIAN DRUGS – our monthly magazine - is For AdvertisingprocessesHave forin youthe all stakeholdersClassified renewed Columns Myour involved,embership M embershipand which also prioritize for series for the advertisements E-mail: [email protected], Have you renewed your Membership for the Mr ChettiarMr Chettiar (+9820629907) (+9820629907) Publications Publications Department DepartmentE-mail:available [email protected],ONLINE. In order to enable you to have access of please contact:Mr Chettiar (+9820629907) Publications Department IDMA BulletinIDMA LI Bulletin (11) 15 LIto (11)21 March 15 to 202021 March Website 2020 : 5 5 safetyYear while 2019-2020 not slowingIDMA Bulletin IDMAdown & Bulletin LIaccess2020-2021 (11) 15LI to (11)to critical21 15 March to 21 new 2020 March 2020 5 Indian5 DrugsWebsite online, kindly: www.idma-assn.org, arrangewww.idma-assn.org, to E-mail us your updated email ID on Year 2019-2020 & 2020-2021 [email protected] / [email protected] IYftools. not,ear Ypleaseear 2019-2020 do 2019-2020so; kindly contact & IDMA2020-2021 & Secretariat2020-2021 at: If not, please do so; kindlyIDMA contact IDMA BULLETIN Secretariat at: IDMAIDMA BULLETIN BULLETIN For morewww.indiandrugsonline.org details, please contact: Publications Department : Ifs not,Email:Email:I "UILDf pleasenot, [email protected] [email protected] AND please do MAINTAIN so; do kindly so; PUBLIC / [email protected] contact CONlDENCE/ [email protected] contact IDMA INI DMA Secretariat THE APPROVAL Secretariat at: at: Tel:022-24944624/ 24974308 / Fax: 022-24950723 / E-mail: mail_idma@ Tel.: 022 - 2494Tel.: 0224624 - 2494 / 2497 4624 / 43082497 4308 / Fax: / Fax: 022 022 - 2495 0723 0723/ E-mail: [email protected],Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723/ E-mail: Email:Email: Tel.:[email protected] 022 [email protected] - 2494 4624for /diagnostics, 2497 4308 / [email protected] / Fax: /therapeutics, [email protected] 022 - 2495 0723 and Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 -idmaindia.com 2495 0723/ / web: E-mail:www.idma-assn.or g / www.indiandrugsonline.org Website: www.idma-assn.org, www.indiandrugsonline.org [email protected],[email protected], Tel.: Tel.:022 - 0222494 - 24944624 /4624 2497 / 43082497 4308/ Fax: / 022 Fax: - 2495022 -0723 2495 0723 IDMA Bulletin LI (11) 15 to 21 March 2020 5 Website:Website: www.idma-assn.org, www.idma-assn.org, www.indiandrugsonline.org www.indiandrugsonline.org IDMA Bulletin LII (05) 01 to 07 February 2021 40 IDMA IDMABulletin Bulletin LI (11) LI (15) 15 15to 21to 21 IDMAMarch April Bulletin 20202020 LI (37) 01 to 07 October 2020 IDMAIDMA IDMA BulletinBulletin Bulletin XLVIII11 LIXLVII (12) (04)(44) 22 5 to22 30 to March30 NovemberJanuary 2020 2017 2016 39 403829 IDMA BulletinIDMAIDMA LIBulletin Bulletin (18) 08 LI LI to(21) (22) 14IDMA 01 May08 to to 202007 Bulletin14 June June 2020 LI2020 (28) 22 to 30 July 2020 IDMAIDMA BulletinBulletin LI24LI (11)(16) 152285 toto 2130 MarchApril 2020 2020 36 3431 IDMAIDMA Bulletin Bulletin LI (11) LI (11) 15 to 15 21 to IDMAMarch 21 IDMAMarch Bulletin 2020 Bulletin 2020 LI (12) LI (12)22 to 22 30 to March 30 March 2020 2020 5 5 16 16 INDIAN DRUGS ONLINE For AdvertisingPU inBLISHED the ON 28th OF EVERY MONTH ClassifiedADVERTISEMENT Columns and BANNER also RATES FOR INDIAN DRUGS WEBSITE for Series Advertisement(Rates in Rupees per insertion) 331,Kalyandas Udyog Bhavan,Century Bazar Lane, Position Size RATES VALIDITY Worli, Mumbai-25 DRightiscount Side Banner 180 X 150 Pixel 25,000 3 MONTHS PleaseLeft Side contact Banner : 180 X 150 Pixel 25,000 3 MONTHS NEED MANPOWER FOR Terms and Conditions All paymentsAdvertising by DD in advance Dept. only to be made in favour of Indian Drug Manufacturers’ Association, payable at YOUR COMPANY? Mumbai “We are a leading job placement 25% discount applicable only for IDMA members consultant working for the Pharma Industry IDMA 15% discount is applicableBULLETIN on Annual Contract for Non IDMA Members with excellent candidate profiles Please provide Banner Artwork as per the size for advertisements before the deadline to suit all your requirements.” Tel.:Advertisement 022 - material 2494 must 4624 reach / us 249710 days before the date of release Contact: 4308 / Ext.:For more103 details please contact Publications Department Gargi Mukherjee: 9987799131/02232261414 Indian Drug Manufacturers’ Association email: [email protected] Fax: 022102-B, - 2495 Poonam Chambers,0723 Dr/ A E-mail:B Road Worli, Mumbai 400 018. Tel: 24944624/24974308 Fax: 24950723 Candidates can also register their resume at Email: [email protected]/ [email protected]. / Website: www.idma-assn.org / www.indiandrugsonline.org email: [email protected] [email protected]
IDMA Bulletin XLVII (48) 22 to 30 December 2016 48 IDMA Bulletin XLIV (14) 08 to 14 April 2013 43
LICENSED TO POST WITHOUT PREPAYMENT LICENCELICENSED NO. TO MR/Tech/WPP-337/West/2018-20 POST WITHOUT PREPAYMENT RNI REGN.LICENCE NO. 18921/1970, NO. MR/Tech/WPP-337/West/2018-20 REGN.NO.MCW/95/2018-20 RNI REGN. NO. 18921/1970,th th REGN.NO.MCW/95/2018-20st th Published and Posted on 7 th, 14 th, 21 stand 30 th of every month This issue postedPublished at Mumbai and PostedPatrika onChannel 7 , 14 Sorting, 21 and Office 30 onof every30.11.2020 month This issue posted at Mumbai Patrika Channel Sorting Office on 30.05.2020
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IDMA Bulletin LI (44) 22 to 30 November 2020 44 IDMA Bulletin LI (20) 22 to 30 May 2020 40 Webinar on “Accelerating and De-Risking Your Product Development” on the 11th of February, 2021 at 4.00 pm
Aptar Pharma and Indian Drug Manufacturers Association (IDMA) is organizing a Webinar on “Accelerating and De-Risking Your Product Development” on the 11th of February, 2021 at 4.00 pm. The Webinar shall be presented by: Mr. Guillaume Brouet, Vice President, Analytical, Regulatory and Scientific Affairs For the past several decades, Aptar Pharma has been providing drug delivery solutions that help improve and save patient lives. Aptar Pharma, who are our Members, have now diversified into a new vertical called “Aptar Pharma Services”. Under this vertical, Aptar has acquired several companies like Nanopharm, NextBreath, Gateway Analytical and Noble to help you accelerate and de-risk your product development. Aptar Pharma provides end-to-end services from formulation development and device selection to clinical trials to regulatory support for product filing to providing support for market launch and post launch. This webinar showcases how Aptar Pharma can partner with you at each stage of your product development to improve your speed to market and help you decrease risk and cost. Kindly note that there are no registration fees for this webinar but prior registration is compulsory – Please find attached the registration link for the webinar Registration Form https://forms.office.com/Pages/ResponsePage.aspx?id=PkrXX3rVDkGNfALE3wYiNJy-VMACbV9EkT93X48B8mlUR Uc0WU1IUzJISDdCSjhMR0ExTUdSQkowQi4u Please note that after receipt of your registration form, the attendee link will be shared with you. Looking forward to your support and participation in making this webinar a grand success. Thanks & regards,
Daara B Patel Secretary – General IDMA
Indian Drug Manufacturers’ Association Prachi Singhai 102, A Wing, Poonam Chamber, Manager‑Marketing & Communication, Dr. A. B. Road, Worli, Mumbai-400 018. India & S E Asia Maharashtra, India. Aptar Pharma Tel No. 022 24974308 / 24944624 R‑854, TTC Industrial Estate, Thane Belapur Road, Website: www.idma-assn.org Rabale, Mumbai, Maharashtra 400701, India (phone) +91 22 6195 1946 | (mobile) 00 91 9892026098 [email protected], www.aptar.com
IDMA Bulletin LII (05) 01 to 07 February 2021 41
PUBLISHED ON 7th, 14th, 21st and 30th of Every Month ADVERTISEMENT TARIFF (Effective from 01.11.2017) Magazine Size: 21.5 cm x 27.5 cm / Print Area: 18.5 cm x 23.5 cm
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IDMA Bulletin LII (05) 01 to 07 February 2021 42
IDMA Bulletin LII (05) 01 to 07 February 2021 43
IDMA Bulletin LII (05) 01 to 07 February 2021 44
LICENSEDLICENSED TO TO POST POST WITHOUT WITHOUT PREPAYMENT PREPAYMENT LICENCELICENCE NO. NO. MR/Tech/WPP-337/West/2021-23 MR/Tech/WPP-337/West/2018-20 RNIRNI REGN. REGN. NO. NO. 18921/1970, 18921/1970, REGN.NO.MCW/95/2021-23 REGN.NO.MCW/95/2018-20 PublishedPublished and and Posted Posted on on 7 7thth, ,14 14thth, ,21 21stst and and 30 30thth of of every every month month ThisThis issue issue posted posted at at Mumbai Mumbai Patrika Patrika Channel Channel Sorting Sorting Office Office on on 07.02.2021 30.10.2020
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