Govt to release policy to improve bulk drug capacity: Subburaj

Other topics at the ASSOCHAM Pharma Summit included changes in drug pricing, the impending revision of NLEM-2011, and amendments in compensation guidelines and clinical trial approval process

Dr VK Subbburaj, Secretary, Departmetn of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of India addresses the ASSOCHAM Pharma Summit

Viveka RoychowdhuryNew Delhi

Expressing concern over the nation’s dependency on other countries for bulk drugs, Dr VK Subburaj, Secretary, Department of Pharmaceuticals (DoP) said that the government is currently studying the proposals submitted by a committee headed by Dr VM Katoch, Secretary, Health Research based on suggestions from industry.

He indicated that after processing the details, the government will come out with a policy in two months time, to ensure that bulk drug capacity will improve in the next decade. He declined to share details as the policy would first have to go to the Cabinet for perusal and approval. He was speaking at a Pharma Summit recently organised by the Associated Chambers of Commerce and Industry of India (ASSOCHAM) in Delhi.

Inaugural session of the ASSOCHAM Pharma Summit

“More than 80 per cent of bulk drugs come from one source — China — so we want to reduce this dependency,” said Subburaj. Similarly, as much as 75-80 per cent of medical devices are imported and here too, the secretary indicated that all concerned departments are working in tandem to reduce India’s dependence on imports in the medical devices sector.

The secretary further said that there is a need to boost the sector’s manpower to improve drug quality in India. “We are trying to institute a study very shortly to assess the manpower requirement in the pharma sector for the next 20-25 years.”

Release of the ASSOCHAM-YES Bank Knowledge Report

Commenting on the decreasing growth rate of pharma exports, he pointed out that though total exports has increased, the growth rate has dropped to a mere five per cent (versus 18-20 per cent in previous years) due to procedural delays in product approvals and other factors.

With the theme, ‘Changing Dynamics & The Road Ahead’, the summit was supported by Organization of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers’ Association (IDMA), Confederation of Indian Pharmaceutical Industry (CIPI) and Indian Pharmaceutical Association (IPA).

Dr Jagdish Prasad, Director General of Health Services, Ministry of Health & Family Welfare presided as Guest of Honour while Subburaj was the Chief Guest at the day-long well attended meet.

Changing dynamics

Nishant Berlia, Member, Management Board, Apeejay Stya Group and Svran Group, gave the keynote address where he outlined the changing dynamics and resulting challenges of both the healthcare and pharma sectors.

For instance, while India is on track to achieve the Millenium Development Goals (MDGs), India’s non communicable diseases (NCD) burden, present in rural areas as well, will require a change in healthcare delivery architecture while on the pharma front, Indian companies are struggling with the dichotomy of earning in rupees, but spending in dollars as they have to take their trials outside the country.

Technical session on drug price control related issues and revision of NLEM

Speaking during a session focusing on drug price control related issues and revision of the National List of Essential Medicines (NLEM) -2011, Injeti Srinivas, Chairman, National Pharmaceutical Pricing Authority (NPPA) made the point that efforts to fix the systemic issues in the country’s public healthcare system needed to be buttressed by measures like drug price control and periodic revision of the NLEM. Industry views were presented by AH Khan, Vice President, Corporate Relations, Sun Pharma, Sundeep Kumar, Head, Corporate and Public Affairs, Novartis India, C Venkataraman, Director, Corporate Services, Lupin and Dr Ghulam Moinuddin, Head, Regulatory Affairs, LG Lifesciences India.

Towards consensus, not conflict

The following session on clinical trials unfortunately did not have a regulator present to respond to the industry perspectives presented by Suneela Thatte, VP, global operations, Quintiles India, Anil Seth, General Secretary, Indian Society for Clinical Research and Surinder Kher, CEO, Ecron Acunova. The sentiment was that while the past two years have seen wide pendulum swings, there were signs of moderation in the past few months. They expressed hope that this process of consultation with industry would continue.

Panel discussion on cilnical trials, focussing on amendments in compensation guidelines and approval process

Prof YK Gupta, Head, Department of Pharmacology, AIIMS, New Delhi and Vice Chairman, Core Committee on revision of NLEM 2011 in his special address on the ongoing review of the NLEM-2011 took the audience through a detailed analysis of the issues being considered and parameters being used for the revision.

India’s pharma sector has seen considerable regulatory review in the past two years, with industry sometimes lamenting the lack of transparency and arbitrary nature of the resultant policies. Industry associations have tried to bridge the gap between regulators by organising regular industry-regulator meets in order to promote consensus rather than conflict. One hopes that the action points aired during the sessions of the Summit will help balance the policies currently under review.