Bad Medicine

Updated: Jan 29 2003, 05:30am hrs
Last week, the International Federation of Pharmaceutical Manufacturers Association accused the Indian pharmaceutical industry of producing counterfeit drugs. Doubtless this was an attempt to malign the reputation of Indian generic drugs manufacturers internationally, but a problem does exist at home. Of an estimated 20,000 drug manufacturers in the country, no more than 4,000 are registered. With such a substantial proportion of players out of the regulatory loop reflected in manufacturing set-ups located in garages, non-adherence to Good Manufacturing Practices and suchlike its no surprise that up to 40 per cent of medicines manufactured in the country may be fake. That the same is also a governance issue is clear given the lack of coordination between various regulatory agencies and the nexus between manufacturers, state agencies and health professionals. Which explains why the spurious drug market is estimated to be around Rs 4,000 crore of the Rs 19,000 crore-worth Indian pharmaceutical market today. But much more is at stake than just industrys reputation or governmental revenue. For, unlike intellectual property violations in respect of software, music et al, spurious drugs assume life-threatening consequences for unsuspecting consumers.

For their part, Union and state governments have time and again voiced their concern. The Centre wants to make manufacture and marketing of spurious drugs a cognisable offence under the Indian Penal Code. It has plans to make the post-marketing surveillance system for drugs more efficient. States, too, have vowed to become more pro-active. A Pharmaceutical Research and Development Committee, set up in 1999 and headed by R A Mashelkar, has recommended measures to strengthen the regulatory set-up in the country. Now, another expert committee headed by Dr Mashelkar has been directed to give recommendations on the same within six months. The establishment now needs to walk the talk. Law enforcement even within the existing legislation has to become more effective. Industry, too, must take up cudgels on its own behalf. For instance, it can help plug the existing vacuum in the enforcement process by sending out trained investigators who could work in tandem with under-staffed governmental agencies. And they can voluntarily adopt innovative packaging. Finally, given that consumers of spurious drugs tend to be poor and illiterate, a public awareness campaign should be kicked off simultaneously. After all, if the government can encourage a shakeout for drug suppliers to India, there is no reason why it should dither over a similar shakeout within this country.