Azad and Hamburg met earlier today to sign a statement of intent under which they have agreed to share information on GMP violations and collaborate on drug and API manufacturing facility inspections.
Under the plan, India and the US will exchange “information relevant to lack of compliance with accepted current good manufacturing practices, good clinical practices, or good laboratory practices, as appropriate, by manufactures and sponsors of medical products.”
Regulators from both countries will also engage “collaboratively as observers in medical and cosmetic product and inspections conducted by the other country” and inform the host country of any facility visits before they take place.
News of the accord comes amid renewed questions about the quality of drug manufacturing in India, with major suppliers like Ranbaxy and Wockhardt both recently being the focus of US Food and Drug Administration (FGDA) criticism.
And, while Hamburg did not mention any quality problems specifically, her comment that: “there is huge expectation and dependence of public on the regulator to ensure the quality of [drug products]” clearly indicate that such concerns were a driver for the new partnership.
This was further underlined by her suggestion that: “India and US need to be effective partners and work on transparency” and that “there should be common set of standards so that people have quality, safe and efficacious drugs.”
Cheap doesn’t mean bad
Instead, Azad argued that it is unfair to assume that drugs made in India are lower quality just because they are cheaper than equivalents made by competitors in the west.
“Efficacy of the Indian drugs should not be judged on the basis of their cost as the input cost in India is much less than that in the developing countries due to the less expensive human resources.”
"These medicines while being affordable are as effective as drugs manufactured in the developing countries, he mentioned. He further said that being affordable should not mean that they are ‘cheap and spurious’."
The minister added that: “Developing countries such as India who have a growing pharma industry should be allowed to grow.”
He also said India has taken steps to strengthen its regulation of drug production, citing various planned initiatives relating to oversight of clinical trials, patient compensation and monitoring of active pharmaceutical ingredient (API) facilities as examples.
“Stringent punishment up to life imprisonment is prescribed for those involved in manufacturing or selling of spurious drugs. Special courts have been set up for speedy trails of those involved in such crimes. Moreover, 16 out of 28 states in country have special courts for speedy trials,” he said.
FDA in India
Without more details of the collaboration with the Indian authorities - Central Drugs Standard Control Organization (CDSCO) it is hard to prediict whether the US agency will expand its presence in India.
However, according to comments by Altaf Ahmed Lal, who was appointed as head of the FDA's Indian office last October, the initial focus will be on strengthening the relationship between regulators and industry.