The recent spurt in media reports on "spurious drug menace" and the "incapability" of the regulatory authorities to tackle the problem is causing distress amongst the senior regulatory officials. According to the officials, the spurious drug issue is getting "exaggerated beyond all proportions" in the media and is likely to harm the image of Indian pharmaceutical industry in the international market.
Officials complain that many in the media are playing a "negative role" by carrying reports that have no supporting evidences. Even after the World Health Organisation made it clear that there has been no WHO study to understand the extent of spurious drugs problem in India, publications come out with quotes of "WHO figures" which says that 35 % of drugs produced in the country are spurious, they lament.
Speaking to Pharmabiz.com, Ashwini Kumar, Drugs Controller General of India (DCGI) felt that the forces who are trying to create a negative image about the quality of Indian drugs and who attempt to project the "weakness" of Indian regulatory system are not doing so in the interest of Indian pharmaceutical industry or the regulatory system.
"Indian drug regulatory system is gearing up to face the challenges of future. We are working out long-term plans and programmes intended at the strengthening drug regulatory system. The positive results are to be visible soon," he said.
The DCGI accepted that the enforcement of drug laws is not uniform throughout the country. "There are bad elements within the industry who are indulging in the manufacture of counterfeit / spurious drugs from places where drug regulatory agencies are weak. But that doesn't mean that one out of four drugs available in the country is spurious," he said.
Most other senior drug control officials support the same point. They allege that the forces behind the never-ending negative campaigns are aiming at maligning the entire system.
According to DCGI, a strong and competent drug regulatory system is the first and foremost pre-requisite for Indian pharmaceutical industry in its attempts towards growing global. "The stature of the US Food and Drugs Administration (USFDA) is helping the US pharmaceutical industry in a big way. The stronger the regulatory authority, the better the quality of the drugs that are manufactured in that country," he said.
Kumar wanted Indian pharmaceutical industry to realize the importance of a more efficient drug regulatory system. "Instead of strengthening the system, there is a conscious attempt to malign the system. This will only diminish the prospects of the industry," he explained.
It should be noted that the Mashelker committee set up for suggesting methods of improving the efficiency of drug regulation in the country had in its interim report called for a centralized system. Officials feel that the centralization of drugs control should have been carried out years ago. "That would have made us internationally visible. Even if we are able to introduce the changes now, the industry would tremendously benefit out of it. If every regulatory official has a national vision, and not a state centric one, there would be tremendous improvement in the functioning of the drugs control administrations" they opine.