New Delhi: India’s drug regulator is collaborating with its US counterpart to improve its functioning in several areas including monitoring drugs for adverse reactions, regulating medical equipment and devices, and increasing its international reach.
Discussions between the Drug Controller General of India, or DCGI and the US Food and Drug Administration, or FDA, also cover clinical practices and biological drugs and are expected to strengthen the regulatory capacity of the Indian agency in chemicals-based drugs and in emerging areas where its expertise is seen as inadequate.
Separately, DCGI also intends to initiate inspection of non-Indian plants to ensure the quality of drug raw materials being imported from other countries such as China. US laws require FDA to do this but it is not immediately clear how the Indian regulator will be able to do this without cooperation of foreign governments.
US Food and Drug Administration commissioner Andrew C. von Eschenbach (Photo by: Chris Kleponis/Bloomberg)
“We had discussions with a high level group in US FDA after which five areas of collaboration were identified: medical devices, clinical practices, biological drugs, pharmacovigilance and information technology that can facilitate online submission of data by companies,” said a senior official in DCGI’s office, who was part of the team that visited FDA offices a month ago, but did not wish to be identified as the proposal has not been formally announced.
Pharmacovigilance is the technical term for monitoring quality, safety and efficacy of marketed medicines.
The Indian move comes at a time when FDA is working on plans to open its country offices in Delhi, Mumbai and Hyderabad, as part of a larger plan to have a local presence in India, China, Europe, South America and West Asia. The “FDA beyond our borders” initiative will see “boots on the ground”, FDA commissioner Andrew C. von Eschenbach had said in a January interview. Questions emailed to von Eschenbach on Friday on the collaboration with DCGI were not immediately responded to.
Official sanction from both the US and Indian governments for the collaboration is expected soon, the DCGI official said.
“This is a very positive and constructive development for capacity building in DCGI’s office, especially so when the industry is getting into new drug research and biosimilars,” said D.G. Shah, secretary general of Indian Pharmaceutical Alliance, an industry lobby that represents big pharma companies. Such measures would help contain doubts cast on the quality and safety of Indian medicines, he added.
Medical devices, said the DCGI official, “is our first priority because FDA is very good in (regulating) this whereas India has a very rudimentary system”. DCGI today merely regulates about a dozen types of medical devices including syringes and catheters. A study by audit and consulting firm Ernst and Young predicted the medical equipment market here would grow to almost $5 billion (Rs21,390 crore) by 2012 from $2.6 billion in 2006.
DCGI will also try to learn from FDA’s comprehensive online systems that issue drug approvals, consumer warnings and recalls and maintain a record of patented drugs being sold in the US. FDA has recalled or issued warnings on several drugs in the past, including Bayer AG’s Trasylol, used to stem bleeding in heart surgeries; Avandia, a diabetes drug, and asthma medicine Advair, both from GlaxoSmithKline Plc. and arthritis drug Vioxx of Merck and Co.
Strict compliance to so-called good clinical practices will help India’s drug trial firms, the DCGI official added. Ernst and Young estimates clinical trials to some $839 million revenues by 2012.