This newspaper has reported that the United States Food and Drug Administration, or FDA, has said that Indian companies will have to submit three batches of medicine for inspection from next year, as against one batch currently, when seeking approval to launch in the US. This is expected to push up the cost of doing business in the US for Indian companies. It may also take them longer to get approvals. The measure comes close on the heels of the concern raised by the FDA over the manufacturing practices of Indian drug makers such as RPG Life Sciences and Wockhardt. Several Indian companies have had to recall their products from the US.
Indian companies allege that the FDA has had similar issues with drug makers in other countries as well - including multinational corporations - and the extra attention that Indian cases have received is part of a campaign launched by patent-holding overseas pharmaceutical firms to discredit the country's generic drugs industry. Such defensiveness, however, is beside the point. What matters is that this is a good time for the Drug Controller General of India, or DCGI, to improve regulation. If India wants a slice of the global generic market, which will only grow in size in the days to come as all governments try to control the cost of healthcare, the country will have to upgrade its regulatory framework.
Regardless of the firms' claims, quality is a serious issue when it comes to Indian drug makers. A 2010 report by the International Policy Network found that seven per cent of drugs bought from wholesale traders were substandard, and 3.6 per cent of the drugs from traders contained no active ingredients whatsoever. Some of the spurious drugs contained chalk or talcum powder mixed with a pain reliever to trick and defraud the patient. As many as 92 per cent of pharmacists said they had been offered substandard or spurious drugs for cheaper prices. There are other malpractices as well, related to regulation. The parliamentary standing committee on health and family welfare found that expert opinions necessary for drug approvals were ghost-written by the companies that had sought the approvals. Reports sent in by different experts on the same drug were found to be exact copies of each other - with the same errors! Documentation maintained by the companies is often inadequate. Audits of factories and their processes seldom take place. The whole space of clinical trials is a grey area. Until recently, the government did not have a clear fix on the number of deaths that occurred during clinical trials.
One reason for this state of affairs is that there are thousands of drug makers in the country, and the DCGI doesn't have enough manpower to monitor all of them. Thus, it is of utmost importance that the regulator recruit people quickly. And, to avoid further regulatory issues, India should become a member of the Pharmaceutical Inspection Convention, an association of drug regulators who agree to stick to internationally specified and accepted standards. It is estimated that it will take India five years to raise its regulatory ecosystem to that level. The task must start now.
