The new patent regime will harm the interests of the developing nations, slow down both the discovery of new drugs and their diffusion, and will raise drug prices all over the world, according to Amiya Kumar Bagchi, noted economist with the Institute of Development Studies, Kolkata.

In a presentation at the two-day national seminar in Kolkata on Pharmaceutical Policy and Access to Essential Medicines, last week, he noted that even the WTO agreement provided a considerable degree of flexibility in policy making for public health, and the policy of gradually abolishing drug control was not mandated by that agreement. However, the drive in this direction in India had been piloted by the greed of the MNCs and their collaborators in India. The current TRIPS regime under WTO was brought about by a long conspiracy by the chief executives of Pfizer, the biggest DPC in the world, who then persuaded or bullied other multinational companies in G-7 countries to join the conspiracy.

In this era of neo-liberalism, which has become influential in policy making, practically no revolutionary drug to fight the diseases of the poor has been innovated. This trend is likely to persist, unless India, in cooperation with other developing nations and watchdog organizations like WHO fight to overturn the TRIPS regime in WTO. He noted that even though the drug companies in India had gained enormously from the enforcement of the process patent regime from 1972, they invested only a fraction of their revenues in R&D. One result has been that many of these companies were more keener to collaborate with multinationals as subcontractors than developing medicines for neglected diseases or old diseases that have become resistant to the current drugs, said Amiya Kumar Bagchi, also the chairperson of the Organizing committee of the seminar.

In another presentation, Dr.Avijit Hazra, Unit Coordinator of Community Development Medicinal Documentation Centre, Kolkata, said the quality of drugs was a global phenomenon and the quality scene in India was complex, confusing and not satisfactory. India had numerous manufacturers, brands and generics, substandard and counterfeit pharmaceuticals in circulation. There was no control over indigenous systems medicines, food supplements passed as drugs, promotional claims, and lacks a complaints redress mechanism accessible to the public, he added.

Medicines available in government hospitals are inferior in quality, and most of the physicians prescribe only branded drugs forcing patients to approach private vendors. Some patients also hold the same view, and the generic movement can never take off if poor quality products are off loaded in the name of generic supplies, he noted.

In India, the drug administration does not have the manpower, machinery, time or energy to chase the violators and have cumbersome legal procedures. The drug control machinery must be given more teeth to bite when offences and violations are detected. Transparent protocol for GMP inspection of manufacturers, mandatory post-marketing surveillance of drugs, stringent labelling provisions, special cell to tackle misleading drug promotions etc. are some of the suggestions to strengthen the DCAs, he opined.

The recently launched National Pharmacovigilance Programme needs to be utilized to its full capacity to generate India specific data on ADRs, which also provide signals indicating quality failure, said Dr Avijit Hazra.

The seminar was organized by the Jana Swasthya Abhiyan (JSA), the Federation of Medical Representatives Association of India (FMRAI), the National Campaign Committee for Drug Policy (NCCDP) and the All India Drug Action Network (AIDAN), in association with the Indian office of WHO, to develop a comprehensive reference volume on the domestic pharmaceutical sector and pharmaceutical policy for the coming decade.