Section Pharmaindustry Commentary

A Review on the Current Classification and Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the light of Present Day Context

Prashant Tandon1, Varun Gupta2, Ashish Ranjan3, Purav Gandhi4, Anand Kotiyal5, 3 Aastha Kapoor 3 1Founder ;2VP & Head Medical Affair; Manager Medical Affair; 5Drug Data Analyst Medical Affair, 1mg Technologies Private Limited, 4th Floor, Motorola Building, MG Road, Sector 14, Gurugram, Haryana, 122001. 4Founder, Remedy Social, C/602, Tulip Citadel, Shreyas Tekra, Ambawadi, Ahmedabad 380015, Gujarat.

ABSTRACT______

Background: Current classification of medicines in Conclusions: We have recommended a revised drug India under Drug and Cosmetic Act into Schedule G, classification system that is more comprehensive in coverage and H, H1, X is outdated, evolved through patchwork over eliminates the overlaps between classes. Moreover, considering the years and needs to be thoroughly updated. The the implementation challenges for such a drug classification primary aim of the scheduling system is to ensure system in the diverse and fragmented ecosystem in India, we appropriate access to medicines while balancing recommend a technology backed platform to help monitor the public health and safety. India is experiencing a rapid implementation. transition with the rising burden of chronic non- communicable diseases where regular access of Key words: Drug Classification System, Drug and Cosmetic Act affordable medicines is critical for chronic disease India, Digitization of Prescriptions, Drug Schedules in India, management to prevent complications. Methods: We Schedule H, Monitoring Drug Schedule System analyzed drugs commonly selling across India, Received: 01.09.17 | Accepted:16.09.17 through multiple information sources including 1mg drug database, PharmaTrac (AIOCD-AWACS), Corresponding Author inventory data from distributors and retailers, Dr. Varun Gupta performed extensive literature review and expert 4th Floor, 1mg Technologies Private Limited, Motorola Building, MG interviews. We studied different regulatory systems Road, Sector 14, Gurugram, Haryana 122001 globally to understand best-practices and identify recommendations. Results: We identified series of How to cite this article: Tandon P, Gupta V, Ranjan A, Gandhi P, lacunae in current drug classification system and its Kotiyal A, Kapoor A. A Review on the Current Classification and implementation. Out of approximately 1,600 Regulatory Provisions for Medicines in Drug & Cosmetic Act, in the commonly prescribed medicines, only 656 are light of present day context. Int Arch BioMed Clin Res. 2017;3(3):I- VII.DOI:10.21276/iabcr.2017.3.3.26 currently covered under the four Schedules. There are multiple overlaps in terms of drug substances covered Source of Support: Nil, Conflict of Interest: None under these schedules resulting in ambiguity.

Copyright: © the author(s) and publisher. IABCR is an official publication of Ibn Sina Academy of Medieval Medicine & Sciences, registered in 2001 under Indian Trusts Act, 1882. This is an open access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited

INTRODUCTION______Drug and Cosmetic Act has not been reviewed in a have been amended from time to time. Several efforts have comprehensive manner since its inception although the rules been made in the last 15 years, since the Mashelkar Access this article online Committee Report (2003) appeared.[1] Since then, there have Quick Response code been many proposals for reform including the Department- Website: www.iabcr.org Related Parliamentary Standing Committee on Health and Family Welfare 59th Report on the functioning of the DOI: 10.21276/iabcr.2017.3.3.26 Central Drugs Standard Control Organization (CDSCO)

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(2012) (henceforth, the 59th Parliamentary Committee followed by other classification systems, we arrived at a Report) and the Ranjit Roy Chaudhary Committee Report recommendation for a new classification system and (2013) and most recently, the Drugs and Cosmetics mapping of certain classes of drugs for the same. (Amendment) Bill, 2015.[1] However, despite these efforts large lacunae remain in terms of classification of medicines RESULTS & DISCUSSION ______into different schedules. The current classification of Challenges identified with current Drug Scheduling medicines in Schedule G, H, H1, X is outdated, evolved system: through patchwork over the years and needs to be thoroughly Current drug classification system primarily focuses on five updated. drug classes including Schedule G, H, H1, K, and X. A brief The primary aim of the scheduling system is to ensure overview regarding definition of these drug classes and appropriate access to medicines while balancing public related regulatory guidance is provided in the Table I. health and safety. India is experiencing a rapid transition with the rising burden of chronic non-communicable diseases where regular access of affordable medicines is Table I: An overview of current Drug Schedule classification No. of Drug Prescription critical for chronic disease management to prevent Definition [3,8] Medicines Schedule Guidance complications. A robust scheduling system framework, Covered[3] Schedule G consists for drugs implemented using some of the recent technological that can be administered only advancements can result in improvement in access of Schedule G under supervision of a 57 None medicines without compromising the public safety. Registered Medical Practitioner (RMP) In this review, we focus on highlighting the challenges Schedule H consists of drugs Medicines to confronted due to current schedule classification of which are required to be be sold only Schedule H dispensed on prescription of 537 on medicines available in Indian market and potential Registered Medical Practitioners prescription mechanisms to re-classify all the medicines for clarity and (RMP) of a RMP Medicines to better implementation. Presently, a large no of drugs are not be sold only classified under any of the schedules, leading to confusion at Schedule H1 consists of drugs on multiple points. Additionally, may drugs that have globally including , habit prescription forming drugs and a few anti TB of a RMP; Schedule moved to OTC have not been examined in Indian context. drugs which were abused under 46 pharmacist H1 These recommendations can be considered while making Schedule H, and now have a to maintain a regulation on its sales and register/recor amendment in the Drug and Cosmetic Act and Rules. additional warning to the patient d of all medicines sold METHODS______One of the aspects of this schedule is the list of drugs that We took the following approach for this study: Not clearly Schedule K can be sold without a license, None defined We identified a complete universe of drugs commonly and doctors can directly selling across India, through multiple information sources dispense the same. Medicines to including 1mg drug database, PharmaTrac (AIOCD- be sold only on AWACS) [2], inventory data from multiple distributors and Schedule X consists of drugs prescription retailers. Once the entire list was identified, we mapped a list which are required to be of a RMP dispensed on prescription of of approximately 1,600 unique drug substances present prescription Schedule X Registered Medical Practitioners 16 copy to be across these medicines, and classified them across various (RMP) preserved for It requires special retail license disease areas. two years for selling these medicines. We conducted a systemic analysis of all the 1,600 drug and records of all substances to map them under Schedule G, H, H1, and X, medicines based on the latest edition of Drug and Cosmetics Act[3] and information available on product labels and images. Current drug scheduling system faces a challenge of being We conducted multiple interviews with expert physicians, non-comprehensive on multiple accounts including but not pharmacists, Industry experts and ex-regulators to better limited to the following: understand the gaps in current scheduling system and get recommendations on improvements. i) Out of 1,600 odd medicines commonly prescribed in We also analyzed different regulatory systems including India, only 656 are currently covered under Schedule H, United States Food and Drug Administration, Medicines and H1, G or X.[3] Because of this lacuna, many commonly Healthcare Product Regulatory Agency in UK, Therapeutic prescribed medications have no clear prescription Goods Administration scheduling system from Australia, guidance. Some of the examples are included in Table II. and the World Health Organization, to identify some of the Current lack of classification for these drugs results in a [4-7] best practices being followed by these agencies. scenario where deciding the drug classification for these Using our inputs from the above study and our medicines is open to interpretation for all stakeholders understanding regarding clinic usage and pharmacological including the Registered Medical Practitioners, class of each medicine, potential risks and best practices pharmacists, manufacturers and the regulators.

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Table II: Examples of Categories & Substances not covered label, b) Levonorgesterol (emergency contraceptive) is under current Drug Schedules mentioned in Schedule H but label do not contain any Drug Category Drug Substance information. iv) Current Drugs and Cosmetics Act does not cover any Thyroid hormone Thyroxine food or related supplements under any of the schedules. Anti-epileptic drugs Carbamazepine E.g. L-carnitine is mentioned under schedule H but DPP-4 inhibitors Sitagliptin Doxofylline many products are available in market as food Theophylline & its derivatives Theophylline supplement with approval from Food Safety and Mucolytics Acebrophylline Standards Authority of India (FSSAI). Similarly, the Serotonin antagonists (5-HT3 antagonists) Ondansetron current system fails to differentiate some of the more Sulfonylureas Glipizide advanced supplements such as nutraceuticals and Angiotensin receptor blockers(ARB) Azilsartan Beta-blocker Bisoprolol vitamin supplements which need to be administered Calcium channel blockers- Dihydropyridines under physician supervision as an overdose might lead Cilnidipine (DHP) to potential side-effects. For example, overdose of Nootropic agent Citicoline Vitamin A & Vitamin D leading to hyper-vitaminosis is Selective Seretonin Reuptake inhibitors Dapoxetine [10,11] (SSRIs) a fairly noted phenomena. Sodium-glucose co-transporter 2 (SGLT2) v) Schedule G contains a list of 50+ drugs including some Canagliflozin inhibitors antihistamines with a label requirement as per Rule 97 stating that ‘Caution: it is dangerous to take this ii) There are multiple overlaps in terms of drug substances preparation except under medical supervision’.[3] This covered under Schedule H, H1 and X, leading to raises a question if these medicines can be dispensed implementation challenges and leaving decisions open without a prescription, and if these drugs should be a to interpretation. For example, Antibiotics and habit- part of both Schedule H and Schedule G, or if guidance forming medicines are being covered in each of these under Schedule G should have been amended to schedules. Schedule H lists a broad line item (no-32) provide further clarification. The Schedule G is an called as antibiotics, despite many common antibiotics outdated schedule with no clear guidance for the like Amoxicillin, Azithromycin, Amphotericin B etc. stakeholders.[9] are not covered as separate line items, leaving scope for vi) One of the aspects of Schedule K is the list of drugs interpretation.[3] Many higher antibiotics being covered that can be sold without a license, and doctors under Schedule H1 but the list in not comprehensive. dispensing the same. There should be list of substances Schedule X primarily covers habit forming drugs, which can be sold without a license, and this needs to which have the potential of being abused. However, be clearly differentiated from OTC medicines. some of the habit-forming drugs are still covered under Currently this includes products such as calcium Schedule H and H1. For example, Schedule H contains preparations without vitamins, antiseptic lotions, barbituric acid, phenobarbital, phenothiazine etc. and medicated mouth washes/rinses, cough and cold Schedule H1 contains drugs such as diazepam, preparations without antihistamines or substances , midazolam, pentazocine, etc. which also are included under NDPS Act, etc.[1] However, given high habit forming medicines and have abuse potential. disease prevalence and the need for improved access to Moreover, Schedule H mentions barbituric acid & basic care, this schedule should be reviewed phenobarbital, while Schedule X mentions barbitals, comprehensively and more products could be , etc again leaving room for considered as an addition to this list to ease their access. interpretation on classifying certain drugs. Schedule H This could include substances used for household also lists a broad line item as Narcotic Drugs listed in cleaning and disinfectants that are used in a diluted NDPS Act 1945 (no 346).[3] Most of medicines in form, or other such substances which are not meant for Schedule X are not used clinically and is again direct human application but have a preventive usage. outdated.[3] The prescribed standards of compliance for vii) There is no definition of habit forming medicines in the Schedule H-1 medicines to prevent abuse are current drug schedules. Drugs covered under NDPS incomplete and require lot of investment of human Act[12] are currently included in all of Schedule H, H1 resource to conduct inspections to check for and X.[3] All drugs acting on central nervous system are compliance. not habit-forming drugs, only some of the medicines iii) As per the Drugs and Cosmetic Act and Rules there is (example: ones used for producing sedation or no separate category of drugs called OTC drugs. euphoria) have a high abuse potential. Moreover, there Currently those drugs, which are not covered under is a need for some objective guidelines on evaluating Schedule H, H1, X or G and their formulations are the abuse potential of every drug. considered OTC.[1] There is need to prepare the list of viii) Current drug schedule system does not present any such medicines. E.g. a) Nicotine 4mg is labelled with clear guidance for classifying fixed dose combinations caution whereas Nicotine 2mg do not contain such

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where two or more drug substances within the Our Recommendation based on the current study: combination belong to different classes. Based on our analysis of current medicines available in the ix) Currently there is no specific guideline for topical market and inspired by reviews of multiple drug medications. According to D&C, if the drug substance classification systems, we arrived at a framework for follows this criterion, it will have covered under classifying all medicines into five categories described in Schedule H. “The salts, esters, derivatives and Table III. preparations containing the above substances excluding those intended for topical or external use Table III: Recommended Drug Classification System (except ophthalmic and ear/nose preparations Drug Definiti Description Prescription Class on Guidance containing antibiotics and /or steroids) are also covered Over the Includes medicines that do not require a [3] Class counter Prescription by this Schedule.” However, topical preparations of prescription form a Registered Medical I medicin not required Practitioner (RMP) certain drugs are not the same as their oral formulation. es Prescription x) As per the drugs and Cosmetic Act and Rules there is Prescrip Includes all prescription medicines and from RMP Class tion will need to have a valid prescription no monitoring of drugs being prescribed by AYUSH required II medicin from a Registered Medical Practitioner (physical or practitioners. However, as these medicines gain more es (physical or scanned) to be dispensed scanned) adoption, it is imperative that safety and efficacy of Includes all the antibiotics and will need Prescription to have a valid prescription from a RMP these medications also be reviewed and monitoring from RMP Class Antibioti after following appropriate diagnostic required over time. List of prescription medicines needs to be IIIa cs guidelines; digital record of the (physical or prescription and patient to be stored and identified in alternative system of medicine. scanned) archived Prescription Includes all the antibiotics being used in Moreover, current drug classification system also presents a from RMP severe infections and having a higher required series of implementation level challenges, given the dynamic Higher risk of developing resistance; required Class (physical or antibioti Registered Medical Practitioner to nature of healthcare system in India. Some of the key IIIb scanned). cs follow appropriate diagnostic guidelines Prescription to challenges identified by us during this study include: along with mandated culture sensitivity be uploaded tests to prevent drug resistance on the e-portal. i) In India, the pharmacy industry is widely fragmented Prescription Habit Includes all the habit-forming medicines from RMP throughout the country, with around 8- 8.5 Lac licensed Class forming with a risk of being abused, and hence required; IVa medicin usage of which need to be tightly Prescription to retail drug sale premises. Due to this there are a series es regulated be uploaded of compliance challenges including: on the e-portal. Habit Includes all the habit-forming medicines • Lack of pharmacists and patient counseling mechanism forming Prescription with a very high risk of being abused, medicin from RMP and dissemination of drug information to the patients. ideally overlapping with the drugs Class es (with required; included under current NDPS Act; • Sale of drugs without prescription, thereby leading to IVb high Prescription to usage to be tightly regulated with abuse be uploaded drug abuse additional special license requirement potentia on the e-portal. for dispensing these drugs • Lack of records for sensitive medicines like Schedule l) Class Includes all the medicines that are H1 Banned Not to be sold V currently banned in India • Lack of efficient mechanism of recall of not of standard or prohibited drugs declared, Sale of drugs to the patient Moreover, we suggest a few additional recommendations to without bill may lead to traceability and loss of tax help deal with ambiguity in interpretation of the above drug collection. classification system: ii) Current drug classification system does not provide a i) Development of a drug schedule that classifies all the clear and transparent framework for allocation drug over-the-counter (OTC) medication and nutraceuticals, substances to a schedule. New evidence is being and hence helps in effective monitoring of the same. generated for all medicines on a regular basis, Moreover, a classification system of this nature will describing in an effective manner regarding its safety allow for shifting some of the prescription medication and efficacy profile. Also for antibiotics, the resistance into this category after careful consideration, so as to patterns are continuously evolving and as a result their improve access to the same. The WHO has released a classification needs to be revisited on a regular basis. guideline that may help sponsors in determining the Given this dynamic scenario, there is a need for shift from prescription medication to OTC. Guidance regularly revisiting the classification of drug schedules suggests that the product must have the following to ensure its relevance to changing evidence and characteristics.[16] resistance patterns. iii) Number of new medicines and medicine categories are • Sales volume is high enough during the period of being introduced in the market on a regular basis. marketing to determine that the product is extensively Current Schedule classification does not provide a for a used by the consumer transparent guidance framework on where to place the • Product has been made available in the previous new medicines. As a result, there is a long waiting prescription status for enough years. This period varies period until the Schedules are notified before the new from country to country. medicines are classified.

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• Post-market studies data shows no particular cause for are classified under a drug schedule and published. concern and there are no serious adverse events that However, to ensure that there are no delays in getting have increase unduly in frequency during the marketing these new drug substances to patients, a time bound period. process needs to be developed and guidelines will have to be published for the same. Table IV includes list of medicines switches from vi) Develop a clear framework for up and down regulation [17] prescription medicine to OTC category by the US FDA. of drug substances across drug classes, and develop an

evaluation body that would revisit the classification of Table IV: Drug Substances switches from prescription to OTC each drug substance on a periodic basis. Therapeutic category by US FDA Goods Administration (TGA) of Australia conducts Year of switch such an exercise on a regular basis and publishes the [5] Drug Category Drug Substance (DD-MM- same for comments from interested stakeholders. YYYY) Moreover, considering the implementation challenges for Fexofenadine 24-01-2011 H1 Antihistaminics such a drug classification system in the diverse and (second Generation) Levocetirizine 11-01-2017 Cetirizine 09-11-2007 fragmented ecosystem in India, we recommend a technology Fluticasone furoate 02-08-2016 backed platform to help monitor the implementation. Fluticasone proprionate 23-07-2014 Recent public notice issued by the Union Ministry of Health Corticosteroids Adapalene Topical 08-07-2016 and Family Welfare in March 2017 includes plans for an Triamcinolone 11-10-2013 electronic platform will be developed and maintained by an acetonide autonomous body under the Ministry of Health and Family Budesonide 23-03-2015 Esomeprazole Welfare. All wholesalers and distributors will also be 28-03-2014 magnesium required to register themselves on the portal and enter details Proton pump inhibitor Lansoprazole 18-05-2009 of stocks received and supplied by them to further Omeprazole 01-12-2009 distributors or retailers. No retailer, chemist and e- Anticholinergic Oxybutynin 25-01-2013 pharmacist outlet shall be permitted to sell any medicine or Lipase inhibitor Orlistat 07-02-2007 drug unless registered on the portal. The pharmacy outlets Terbinafine Topical 24-07-2006 will also be required to enter details of all medicines or drugs Anti-fungal Miconazole Topical 02-02-2001 received, sold, returned to the manufacturer or disposed of Clotrimazole Topical 07-12-2001 in any other manner.[13,14] Progestins Levonorgestrel 24-08-2006

Mast cell stabilizers Ketotifen Topical 19-10-2006 However, considering the complexity of such an Expectorant Guaifenesin 29-04-2004 implementation and pragmatically balancing it against the Anti-smoking Agent Nicotine 21-03-2002 need to ensure adequate access to medicines, we recommend Osmotic Polyethylene glycol 06-10-2006 the following: laxatives/Purgative i) Pharmacist should be required to upload only prescriptions for drugs belonging to Class IIIb (higher ii) Development and enforcement of a clear guideline antibiotics), Class IVa and Class IVb (habit forming) where any fixed dose combination falls under the drug based on the proposed classification system, to limit class of a substance with the highest class in the disruption to the existing system and maximize combination. For example, if a fixed dose combination compliance (A detailed list of drugs recommended includes two drug substances within which one belongs under these three classes has been provided in Table V, to Class II and another belongs to Class IIIb, the Table VI & Table VII) labeling, prescription and dispensing guidelines ii) Instead of a central body developing the portal[13,14] they relevant to Class IIIb should be followed. should develop specification for the portal that can be iii) Develop a separate drug classification system for topical used by pharmacies and other stakeholders to upload preparation of each medication, rather than classifying prescription. Such specification be then shared with them in the same class as their oral and parenteral class multiple technology vendors and software providers to improve access without compromising on safety. who can either develop such a portal or integrate the iv) Develop a separate drug schedule for classifying all the same with existing pharmacy management or billing drugs under AYUSH system, and start registering those software. Such an approach will allow pharmacies with medicines and gather evidence for the same. This will multiple options to identify an appropriate portal and lay down the foundation for further classification of integrate it with existing workflow without major these medicines and established more robust regulatory disruption guidance around the same. iii) Central body should develop a central server based v) Develop a process where all new drug substances can be environment where all the uploaded prescriptions are launched in the market only after these drug substances shared and monitoring.

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Figure 1: Suggests an indicative workflow for the proposed 4. United State Food & Drug Administration. Drug Safety and portal based monitoring system: Availability. Available from: https://www.fda.gov/Drugs/DrugSafety/default.htm.[Accessed Aug 2017]. 5. Therapeutic Goods Administration. Scheduling basics. Available from: https://www.tga.gov.au/scheduling-basics. [Accessed Aug 2017]. 6. Medicines & Healthcare products Regulatory Agency. Medicines: reclassify your product. Available from: https://www.gov.uk/guidance/medicines-reclassify-your- product. [Accessed Aug 2017]. 7. World Health Organization (WHO). Guidelines for Regulatory Assessment of Medicinal Products for Use in Self-Medication (Geneva 2000). 8. Ahmad A, Chandra S, Kanth K, Patel I, Parimalakrishnan, Mohanta GP, Balkrishnan R. Changing Pharmaceutical Regulation in India to Promote Rational Use of Antimicrobials. Asian Journal of Biomedical and Pharmaceutical Sciences 2012; 2(15): 1-5. 9. Suggestion from IPA on drug and cosmetic Rule 1945. The Indian Pharmaceutical Association. Available from: CONCLUSION______http://www.ipapharma.org/news/Suggestion%20from%20IPA We believe that the current study lays down a strong %20on%20Drugs%20&%20Cosmetics%20Rules%201945.pdf. foundation for re-evaluating the current drug schedule [Accessed Aug 2017]. 10. Hypervitaminosis A. National Health Portal Of India. Available system, and filling some of the major lacunae in terms of from: https://www.nhp.gov.in/disease/eye-ophthalmology- drug classification and its implication. We would consider /hypervitaminosis-a. [Accessed Aug 2017]. building further on this work and developing robust process 11. Koutkia P, Chen T, Holick M. Vitamin D Intoxication Associated with an Over-the-Counter Supplement. N Engl J recommendations and technology based suggestions for Med 2001; 345:66-67. implementing a more robust drug schedule system in the 12. Ministry of Law and Justice. The narcotic drugs and dynamic and complex Indian healthcare environment. psychotropic substances act,1985. Available from: http://lawmin.nic.in/ld/P- ACT/1985/The%20Narcotic%20Drugs%20and%20Psychotropi Limitations: c%20Substances%20Act,%201985.pdf. [Accessed Aug 2017]. While the current study conducts a comprehensive 13. Report of sub-committee constituted by the drugs consultative assessment of current drug schedule system and its committee to examine the issue of regulating the sale of drugs implementation mechanism, the study has the following over internet under the drugs and cosmetics rules, 1945; 30th September 2016. Available from: limitations: http://www.cdsco.nic.in/writereaddata/Sub- • Study refers to drug classification system for different Committee%20Report%20on%20e-pharmacy.pdf . [Accessed Aug 2017]. countries to draw an inspiration for our framework, it 14. Public consultation regarding regulation of sale of drugs in the does not contain a detailed evaluation of the how each country. Available from: drug has been classified by different countries http://www.cdsco.nic.in/writereaddata/public%20notice16marc h.pdf. [Accessed Aug 2017] • Current study does not consider a detailed classification 15. United State Food & Drug Administration. Prescription to Over- of how topical salts of each drug should be classified, or the-Counter (OTC) Switch List. Available from: how any of the nutraceutical products which currently https://www.fda.gov/aboutfda/centersoffices/officeofmedicalpr oductsandtobacco/cder/ucm106378.htm. [Accessed Aug 2017]. do not have a prescription should be classified 16. World Health Organization (2000). Guidelines for Regulatory • Current study does not comprehensively evaluate Assessment of Medicinal Products for Use in Self-Medication; 2000. Available from: nutraceuticals or OTC drugs or products, or propose a http://apps.who.int/medicinedocs/pdf/s2218e/s2218e.pdf classification for the same [Accessed Aug 2017].

Appendix I: REFERENCES______Table V: Recommendations for Higher Antibiotics under Class 1. Mashelkar D. A Comprehensive Examination of Drug IIIb Regulatory Issues, Including the Problem of Spurious Drugs. Ministry of Health & Family Welfare, Government of India; Table VI: Recommendations for Habit Forming drugs under 2003. Class IVa 2. AIOCD-AWACS, Pharma Trac. 2017. Table VII: Recommendations for Habit Forming Drugs with High 3. Malik V. Law relating to Drugs and Cosmetics. 25 Edition 2016. Eastern Book Company, Lucknow. Abuse Potential under Class IVb

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Table V: Recommendations for Higher Antibiotics under Class Table VI: Recommendations for Habit Forming drugs under IIIb Class IVa Drug Category Drug Substances Drug Class Drug Substance Chlordiazepoxide, Alprazolam, Diazepam, Nitrazepam, Anti- influenza Oseltamivir, Zanamivir, Peramivir Benzodiazepine & Midazolam, Clorazepate, Lorazepam, Clonazepam, Famciclovir, Valacyclovir, Ganciclovir, Anti-herpetic Z- drug Temazepam, Triazolam, Clobazam, Flunitrazepam, Valganciclovir Zolpidem, Zopiclone Direct acting Sofosbuvir, Daclatasvir, Ledipasvir, Velpatasvir Muscle Relaxant Carisoprodol hepatitis C drugs Dextropropoxyphene, Diphenoxylate, Pholcodine, Opioid Tenofovir, Efavirenz, Lamivudine, Atazanavir, Tramadol Darunavir, Indinavir, Ritonavir, Saquinavir, Anti-HIV Nelfinavir, Lopinavir, Raltegravir, Zidovudine, Maraviroc, Emtricitabine, Stavudine Ticarcellin, Piperacillin, Piperacillin with Penicillins Tazobactam, Carbenicillin Table VII: Recommendations for Habit Forming Drugs with High Cefditoren, Cefetamet, Cefixime, Cefoperazone, Cephalosporin Abuse Potential under Class IVb Cefotaxime, Cefpodoxime, Cefdinir, Cefprozil, (3rd, 4th & 5th Ceftazidime, Ceftizoxime, Ceftriaxone, Drug Class Drug Substance generation) Ceftibuten, Cefpirome, Cefepime, Ceftaroline Codeine, Pentazocine, Morphine, Imipenem with Cilastatin, Doripenem, Ertapenem, Meperidine (Pethidine), Oxycodone, Carbapenem Opioid Meropenem, Faropenem Buprenorphine, Methadone, Fentanyl, Cell membrane Sufentanil, Alfentanil, Hydrocodone Colistimethate, Colistin, Daptomycin, Polymyxin B active agent Opioid Antagonist Naloxone, Naltrexone Drug for ADHD Oxazolidinone Linezolid Anesthetic agent Vancomycin, Teicoplanin, Dalbavancin, Phenobarbital, , Glycopeptides Barbiturate Telavancin Lincosamides Lincomycin, Clindamycin Streptomycin, Amikacin, Kanamycin, Aminoglycosides Capreomycin, Gentamicin, Tobramycin, Netilmicin Tetracycline Tigecycline , , , Higher generation Balofloxacin, , , Fluroquinolones Pazufloxazin Anti-leprotic Clofazimine, , Isoniazid, Ethambutol, Pyrazinamide, Ethionamide, , Rifapentin, Cycloserine, Anti-tubercular Capreomycin, Para aminosalicylic acid, Thiacetazone, Prothionamide Anti-fungal for Amphotericin B, Caspofungin, Anidulafungin, Systemic infections Voriconazole, Posaconazole Arteether, Alpha-Beta Arteether, Artemether, Anti-malarial Arterolane, Artesunate

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