Two recent developments outline the serious challenges facing the Indian pharmaceuticals industry. One is the order by a single-judge bench of the Delhi High Court quashing the ban imposed by the Union health ministry on as many as 344 fixed-dose combination drugs. The other is the US pharmaceuticals regulator, the Food and Drug Administration, finding the Halol plant of Sun Pharmaceutical lacking in good manufacturing practices, despite having had the time to set things right since the first “observations” were issued. These highlight the fact that though a leading player in the manufacture and export of generic products, the Indian pharmaceutical industry faces serious quality issues. The key culprit is inadequate regulation. To retain its global status, the Indian pharmaceutical industry needs to be guided by appropriate regulation and not arbitrariness, even if driven by the best of motives. The Delhi High Court order acknowledges that the government had issued the ban in public interest. It is also widely known that “irrational” combinations (different drugs combined in fixed-dosage form), which are harmful or useless, abound and should be banned. But the government went about the job by appointing an expert committee when it should have been guided by the advice of the drug technical advisory board and drugs consultative committee set up under the Drugs and Cosmetics Act. The court order says that drugs can be banned only if they are risky or not having any therapeutic value, but this is a scientific determination that can be done only by a body authorised under the law.
There are two main reasons why Indian drug regulation is inadequate, resulting in there being in the market a good proportion of substandard drugs (even spurious ones are not unknown). One is the duality created by India’s federal structure under which drug regulation is handled by both the central and state governments. In the case of the irrational combinations, the trouble began because several state governments issued licences for their manufacture without the approval of the central drug controller. Good manufacturing practices, which constitute the heart of the matter, cannot be imposed without good drug regulation across states, but this is not the case. Some progress on this front appears to have taken place with seven active state regulators finding 27 drugs substandard. When approached by the media on this, some manufacturers, including multinationals, have stood up for themselves, but as many as 10 of the 18 involved, including some well-known firms, have not replied to media queries.
The other reason why drug regulation in India suffers is because apex central regulation by the Union health ministry is fixated on price control when it should be obsessed by quality concerns. Resources available to a ministry as also the mind space of its leaders are finite. Price control is at best a blunt instrument which requires enormous amount of bureaucratic effort. Worse, it often ends up in litigation, again requiring bureaucratic man-hours to pursue. It is far better to access quality drugs cheaply for the public health care system through bulk purchase at negotiated prices. Several European governments with famed public health services do this. The market can take care of the rest of the consumers who can afford to pay.