Tightening the drug regulatory regime

efforts to amend India’s antiquated drugs and cosmetics law are welcome. But more may be needed

To dismiss claims of poor-quality pharma drugs as an effort by Big Pharma to hurt India’s growing reputation as pharmacy to the world — a non-tariff barrier of sorts — isn’t as extreme a conspiracy theory as some may believe. Yet, to pretend all is well with the drug licensing and regulatory regime would be counterproductive. Which is why efforts to amend India’s antiquated drugs and cosmetics law, including provisions to ensure better coordination between central and state drug regulators, and training inspection teams tasked with monitoring violations, are welcome. It wouldn’t do to have an industry’s reputation spoilt by a few bad apples exploiting regulatory gaps.

The strength of India’s pharma industry lies in hundreds of small and mid-sized firms, at least some of which are focused on export markets. (Mint)

More may be needed. The strength of India’s pharma industry lies in hundreds of small and mid-sized firms, at least some of which are focused on export markets. Any firm exporting drugs realises the importance of adhering to Good Manufacturing Practices (the basic requirement in any export market), including the technical, but critical aspect of documentation — but it is also an area that many take for granted. Not surprisingly, the list of Indian pharma companies that have sometimes failed inspections by the United States’ drugs regulator (the country is a huge export market) reads like a who’s who of the country’s pharma industry.

In the late 1990s, many mid-sized Indian auto component companies benefited from being part of “quality clusters” — an initiative to help them exceed global quality standards. The effort, which involved top Japanese quality gurus, was catalysed by CII. Perhaps the government or the pharma industry body should consider something similar, even as the government works to tighten the regulatory regime.