29 May 2014 By Email/Courier

Dr Harsh Vardhan Hon’ble Minister for Health & Family Welfare Ministry of Health & Family Welfare Nirman Bhavan, Room No. 150-A New Delhi 110 011

Dear Sir,

On behalf of the President (Mr Satish Reddy of Dr Reddy’s Lab) and the Executive Council of the Indian Pharmaceutical Alliance (IPA) and myself, I welcome you as Health & Family Welfare Minister. We wish you success in building a coalition for affordable healthcare.

2. The IPA represents research based national pharmaceutical companies. It consists of the following Members:

Alkem Laboratories Ltd Micro Labs Ltd Ltd Natco Pharma Ltd Cadila Pharmaceuticals Ltd Panacea Biotec Ltd Dr Reddy’s Laboratories Ltd Ranbaxy Labs Ltd Ltd Sun Pharmaceuticals Industries Ltd Intas Pharmaceuticals Ltd Ltd Ltd Unichem Laboratories Ltd J B Chemcials & Pharmaceuticals Ltd USV Ltd Lupin Ltd Wockhardt Ltd Labs Ltd

Collectively, we account for almost 80 per cent of the private sector investment in pharmaceutical research and development. We contribute 60 per cent of the country’s exports of drugs and pharmaceuticals and service over one-third of the domestic market.

3. The national pharmaceutical industry is facing several daunting challenges and very few opportunities. We believe your commitment to the larger national interest could make a difference in tackling these challenges. a. The national pharmaceutical industry has made enormous strides globally. Its strenuous effort has earned India the tag of the Pharmacy of the World. However, we are now judged by the world by image of our Drug Regulatory Authority. The consistently negative assessment of CDSCO by the Parliament and the Judiciary and the omission of any mention of the significant progress in its modernization have the unintended consequences of serious damage to the credibility of the national drug regulatory authority. It adversely affects the reliance that is placed by other countries on drug approvals by the CDSCO and gravely damages the reputation of the national pharmaceutical industry as suppliers of safe, effective and quality medicines at affordable prices. We see that the issues as noted above are being torn out of context all over the world and used by our competitors in other countries to discredit the national pharmaceutical industry. b. We are concerned of the fall out of the 59th Report of the Parliamentary Standing Committee on Health and Family Welfare on the functioning of the CDSCO. The Report had highlighted the need for greater transparency, accountability and efficiency in the working of the drug regulatory authority in the country. Instead, the functioning of the CDSCO has come to a standstill, delaying all decisions related to clinical trials and approval of new drugs. c. We have noted with mounting concern the increasing reluctance in the CDSCO to grant approvals for new drugs, even if they are approved elsewhere in the developed countries and allow clinical trials or bio-studies for exports. This is evident from the significant decline in the grant of drug approvals in the recent periods. d. Small molecule entities with sales of $ 65 Bn are going off-patent between 2012 and 2018. In addition, biologics worth $ 75 Bn are going off-patent over the next five to seven years. However, if their generic/biosimilar versions are delayed or blocked by the CDSCO, the national pharmaceutical industry will lose its shine. Such delays impact the ability of the national pharmaceutical industry to compete in international markets. We are apprehensive that these delays could blunt the competitive edge of the Indian generic industry.

Besides national image and impact on exports, the patient is the biggest loser. Marketing approvals for many new generics/biosimilars are inordinately delayed depriving him of access to safe, effective and quality medicines at affordable prices.

4. In order to address these and many other related issues, it is necessary that your Government ensures expeditious passage of the Drugs & Cosmetics (Amendment) Bill pending for about seven years. The Bill should be modified to incorporate the recommendations of the Parliamentary Standing Committee contained in its 79th Report. It, inter alia, envisages elevation and empowerment of the Drugs Controller General of India.

5. The second major issue stalling the working of the CDSCO and hindering access to affordable medicine relates to an ongoing litigation in the Supreme Court of India (SC WP (33) of 2012). The petitioners are health activists. They are fighting for the rights and protection of clinical trial subjects. However, in the process, they have caused enormous damage to the country and demoralized the working of the CDSCO. It is therefore necessary that your Ministry initiates a dialogue with the Petitioners to allow the CDSCO to function normally; and secondly, you must adopt a reasoned and hardened position vis-à-vis the Hon’ble Court to let the executive function.

6. Likewise, access to modern medicines is an important element of any healthcare programme. In order to provide quality medicines free of cost to deserving patients who cannot afford treatment cost of specified diseases (HIV Aids, TB, Malaria, Cancer, etc.), the pharmaceutical industry is willing to cooperate with the Government to provide required medicines at the special rates. For all other diseases, the Government will need to strengthen its procurement mechanism to ensure access to quality medicines for all. Both these programmes can be so designed that the pharmaceutical industry can cross subsidize access programmes from their private market sales.

7. We request you to give us an opportunity to explain our position on the issues discussed hereinabove.

Thanking you and with best regards,

Yours sincerely, For Indian Pharmaceuticals Limited

D G Shah Secretary General