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Regulatory Hurdles In India

he stringent regulations from international regulatory authorities of US and EU are tightening the noose around the Indian pharma industry. The increasing inspections are driven by the rising violations in manufacturing process, noted Sanjit Singh Lamba, managing director, president, Global Brands Units, head, Global Procurement Strategy, Eisai Knowledge Centre.

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The main reason for being hauled up by a regulatory authority is the high level of risk assessment for each identified hazard. In the case of US FDA when it issues a 483 response format of inspectional observation, it is not adequately addressed by Indian companies. This leaves no option with the US FDA but to issue a warning letter. Companies do not indicate the problem instead they resort to quick fixes. Now the warning letter is perhaps a final alarm notice issued to a company before taking further legal action which includes injunction, seizure and criminal investigation and thus drive the company out of business, he said.

The recent spurt in inspections and nine warning letters are adding to the woes of Indian pharma companies. Much of these issues arise because of the difficulty associated with the manufacturing process that includes not just oral formulations, sterile injectables and biologics, said Lamba.

Highlighting the top ten deficiencies during audits by the international regulatory agencies including US FDA, Lamba said, inadequate quality standards, lack of in-house investigation on batches that fail to meet specifications and no written processes or insufficient standard operating procedures at pharma manufacturing plants not just in India but abroad are seen to be among serious shortfalls.

Since 2008, the number of inspections have increased but in last six months, there has been a significant rise in the number of checks by US FDA and EMA. But the US FDA has now raised the safety concerns of many pharma manufacturers in India, said Lamba adding that Indian manufacturers do not give a view that their facility is on a continuous improvement process.

Further, there are clear indications of no process controls that validate the performance of manufacturing process, with nil maintenance checks on equipment cleaning, poor control of components, intermediates and raw materials besides quality assurance deficiencies, Lamba said while speaking on the ‘Recent Regulatory Trends in Indian Pharma at the inaugural of the two-day Merck Millipore event on ‘The Web of Process & Regulatory Trends’.

Another issue is that once the faults are pointed out by the regulator, companies submit unsatisfactory reports recording only one side of the situation with no details of the full statement that confuses the global investigators. In 2012, under the 10 drug inspection deficiencies indicated, 118 were due to poor adherence to quality processes, 78 of them were failure to thoroughly review and 75 complaints were attributed to absence of written procedures.

“All these issue have forced US FDA to issue warning letters because it has perceived violations to be of serious significance. The FDA does not trust the company to correct the problems sufficiently on its own and sees a lack of seriousness. Failure to establish corrective and preventive action (CAPA) following an investigation is the cause of non-conformities. Early preparation of a warning letter is likely to be based on 483 format which is a guide in the early preparedness to prevent severe lapses. The cost of an FDA enforcement action is more expensive than a cost of a robust compliance process,” said Lamba.

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