mdi ConsultantsBackground:
Around 25% of the drugs being imported into the US are manufactured in India and in the past few years Indian drug makers were not being audit under tight compliance by the FDA. But due to some recent mishaps and bad experiences with some Indian companies like Ranbaxy and Wockhardt, the FDA has decided to come down hard on the Indian drug makers. The FDA is expecting comprehensive and strict compliance to the USFDA cGMP and quality control standards. The FDA foreign inspection program was being lenient when inspecting overseas drug manufacturers. But, the recent bitter developments concerning some of the leading drug makers has pressured the FDA to take some stringent measures against the Indian drug industry, in general.
FDA commissioner’s visit to India and her remarks about the mentality and approach of Indian drug manufacturers:
FDA’s Chief Margaret Hamburg recent one week long visit to India and noted that whenever she visits India most of the Indian drugmakers do not turn up for the meetings and pay a deaf ear to such productive meetings arranged by the FDA. She said that until the last few years, FDA was not doing as many cGMP inspections in other countries as they were in the US and that this scenario is definitely going to change. She also noted that when she goes for drug safety around the world, India often is not there and that it is a loss for India and a loss for the world. Due to this India is not in the good books of the FDA and its impression has already been blackened which can hamper the economy of the country.
Probable Actions proposed to be taken by the FDA:
FDA has planned to widen its regulatory horizon in India. This includes expanding its inspection offices in India and training regulatory officials in there. This will include a general increase in FDA inspections in overseas plants in India. FDA has agreed to a new plan where Indian regulators will shadow inspectors from FDA on plant visits to observe how FDA conducts its inspections. FDA is now going to create an Office of Pharmaceutical Quality to improve FDA’s oversight of all types of pharmaceuticals, from brand name to over the counter. FDA is also working directly with the drug industry to come up with new standards and data that may signal which drug plants are straying from cGMP rules and need to be inspected.
The Drug Controller General of India (DCGI) has been encouraged to go to international meetings on cGMP drug safety regulations which otherwise is the case right now. This will inculcate a sense of realization and importance in DGCI’s policies to follow the FDA standards which in the long run will help Indian drugmakers to abide by the FDA terms.
Present Scenario and FDA’s viewpoint:
At present, India’s drug companies make 25% of drugs in the US. FDA inspections of drug plants in India increased to 195 in 2012, from just 11 in 2002. This is quite an exponential increase and shows that FDA is taking these inspections very seriously.
Hamburg said FDA wants to level the playing field. Wherever that drug is made, if it is being brought to the US, FDA has to make sure that it is being made according to FDA standards and expectations. On February 10th Dr Hamburg signed a “statement of intent” with Keshav Desiraju, of India’s Ministry of Health and Family Welfare, to encourage collaboration between American and Indian regulators.
Conclusion:
From the above article it can be inferred that FDA is expected to expand its regulatory oversight to overseas countries and keep a hawk eye over these country’s regulation procedures. It is high time for India to straighten out their drug approval and manufacturing processes and abide by the FDA rules and regulations. If they had a feeling that nobody is there to scrutinize them, it has been proved by the recent development from the FDA’s side. It would be better if these countries especially India would stand for these regulations being laid down by the FDA and be in their good stead so that it would benefit them in the long run.
mdi Consultants, Inc. has partnered with an India cGMP consulting company in India to assist Indian companies in understanding the FDA cGMPs and dealing with FDA inspections of their operations. For more information on mdi’s partner please email us at [email protected] and reference: India.