Raising the bar

After visiting the Taj Mahal on her recent visit to India, FDA Commissioner Margaret A Hamburg blogged, “those responsible for building the Taj and those that are preserving the centuries old structure are committed to extraordinary quality”. Throughout her visit, she stressed on the importance of quality, linking it to product safety and the possibility of patient harm if quality is neglected.

She left with a promise to increase staff strength in India, so pharmaceutical manufacturing plants in the country can expect an uptick in surprise inspections. Ranbaxy, Wockhardt and other companies from India received about half of the warning letters issued by the US regulator last year. The steep increase in such missives from previous years can be explained by the fact that the US regulator now has a physical presence here.

There is also the theory that this backlash is all about pharma companies in the US protecting their turf, using both GMP and IP to cut to size the ambitions of Indian companies. Secondly, while the US FDA is coming down hard on India, citing it as the second largest supplier of over-the-counter and prescription drugs to the US, it can hardly use the same stick with China, its largest supplier, thanks to the firm stance of the Chinese authorities.

Conspiracy theories aside, Hamburg has it right when she said, “if you want our market, play by our rules.” Most pharma companies have already been toeing the US FDA’s line. At an industry meet organised by the Indian Drug Manufacturers’ Association (IDMA), senior management from some of these companies point out that India has been exporting to the US and other countries for over 25 years. Warning letters and 483s are part of GMP inspections and were dealt with as per procedure. It is only in the last year that investors have become aware of the risk of these issues. One managing director related how they were forced to organise a conference call with investors and pressed to explain that the latest 483 was not cause for panic and had been addressed to the satisfaction of the US FDA inspectors.

Post Hamburg’s visit, companies who have so far eluded the regulator’s lens will no doubt have to engage in introspection. Sustainable compliance will be the buzzword this year and echoing these concerns, Express Pharma’s next issue will focus on some aspects of how this can be achieved.

And in this issue, to mark International Women’s Day, we put the spotlight on a few more women leaders to find out about their journey and suggestions. Hamburg too held a special closed-door meeting with some of the leading ladies in the pharma sector and participants expressed the need to make the industry attractive for women as well as encouraging women entrepreneurs. Here’s hoping that women, who today constitute only 8-15 per cent of the workforce employed in the Indian pharma industry, will swell the ranks in the next few years.

Viveka Roychowdhury
Editor

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