Drug regulation

The apex drug regulator’s decision to conduct inspections of risk-prone manufacturing units across the country jointly with state drug controllers is a much-desired course correction. This, hopefully, would be but one of the several practices that will be put in place to clean up India’s drug regulatory system. The government’s clean chit to Sonepat-based Maiden Pharma, notwithstanding the World Health Organisation’s medical product alert over the Gambian deaths, has apparently triggered a serious relook at the drug regulatory structure. A similar response was, unfortunately, not forthcoming two years earlier, when the deaths of infants in Udhampur were also linked to spurious drugs. Criminally negligent pharma unit promoters should be prosecuted.

The Central Drugs Standard Control Organisation has a lot riding on it. The outcome of the efforts to tighten the regulatory processes and stringent compliance with standard operating procedures will be closely evaluated. India’s standing as a major global player in the pharmaceutical sector has taken a hit. Much of the criticism is directed at the regulatory system. The quality control crisis has been compounded by charges of lax, inefficient and corruption-ridden drug approval processes that do not follow exacting standards applied in other parts of the world.

Zero tolerance to violation of rules is the foundation on which the pharma sector is expected to stand. For regulators, patient safety has to be the foremost priority. Inspiring confidence among customers requires making transparency the hallmark. The right to ask questions has to be upheld. The large drug units that are export-oriented may have the wherewithal for good manufacturing practices, but it’s the compliance by small and medium-scale units that is the problem area. Even in large factories, dual standards being followed for export and domestic supplies cannot be ruled out. In the race for producing cheaper medicines, quality cannot be compromised.