In the last 10 days, two Indian companies have come in for serious observations from the US Food and Drug Administration (FDA) on their non-adherence to current Good Manufacturing Practices(cGMP).
Kilitch Healthcare voluntarily recalled 27 eye drops in the US, due to potential safety concerns after USFDA investigators found unsanitary conditions. The incident was the second eye drops-linked incident in the US involving an Indian drugmaker in about 10 months.
In February, Global Pharma Healthcare had voluntarily recalled its Artificial Tears Lubricant eye drops, due to possible contamination, the USFDA had said. The action followed the US Centre for Disease Control and Prevention’s (CDC) investigations into drug-resistant infections possibly linked to contaminated eye drops, they then said, pointing to adverse events including eye infections, permanent loss of vision and death.
In a separate and ongoing issue, Cipla received a warning letter involving its Pithampur plant in Indore (Madhya Pradesh). The transgressions red-flagged included data integrity and microbial contamination, among others.
Cost of Cutting Corners
Concerns over cGMP is not something that’s surfacing today, nor is it restricted to Indian companies. But it is in the interest of Indian drugmakers to be up to scratch, given their role as a global supplier of medicines and as they step-up into making more specialised medicines, say industry-insiders.
Besides, these incidents do not augur well, against the backdrop of the global cough-syrup linked controversy. It’s been a year since the World Health Organization issued a medical alert on “contaminated” cough syrups from India, potentially linked to the deaths of over 66 children in Gambia. The issue has not seen a final resolution and there have since been other incidents as well — involving cough syrups and eye drops, for example.
Back home, the Central government is looking to tighten norms through the revised cGMP norms or (Schedule M). In August, the Health Ministry gave large companies six months to implement the norms, while small and medium sized companies were given 12 months. Discussions are underway between pharma industry representatives and the Centre to iron out details, and some companies are seeking 24 months, an industry-hand said.
But big and small manufacturers need to follow guidelines to a tee, says Ashishchandra Rao, Partner, Economic Laws Practice, as India is a major exporter of generic medicines to the world.
In fact, the cGMP norms need to be benchmarked to the best international norms, and industry needs to support each other to meet these requirements, he says, pointing to the contract manufacturing practice where large drugmakers get their products made by smaller producers. Further, he says, the laboratory network to test products also needs to be fool-proof, and more laboratories could be empanelled (governed by Government rules) to ensure quality testing.
In fact, the Indian Drug Manufacturers’ Association (IDMA) have had multiple interactions through last month with government officials on cGMP. Viranchi Shah, IDMA-President, says, the aim should be to not leave anyone behind and towards that goal, small manufacturers should be hand-held and supported with technical training and financing.
Of the about 8,000 sites, presently, over 2,100 sites are WHO-GMP compliant, he said, adding that the task now is to upgrade the rest to the same benchmark. But India is on a good track, he points out with over 650 facilities, approved by the USFDA, and about an equal number by the European Union authorities, as well.
Living document
Pharma industry representatives, who did not want to be named, explain that the revised cGMP norms should have a policy statement that outlines the framework and dynamic guidelines that are revised in line with changes in science — something like a “living document”, for example.
Raheel Shah, Business Development Director of BDR Pharma — which makes products for itself and other companies —points out that companies are working to keep pace with the evolving cGMP norms. “It is getting more complicated with more complex and life-saving molecules,” he says, referring to their oncology products. Companies are reworking their systems and processes, when cGMP issues are raised, he points out, adding that it is a learning for all.
On its part, the Centre also comes out with regular reports on “not of standard quality” (NSQ) products, even as it cracks down on units not following cGMP norms. But for the industry grappling with warning letters, import letters and other regulatory observations, it is clear that cGMP requires immediate attention and cannot wait for another day.