As the government begins to correct deficiencies in the drug regulatory process brought forth by a parliamentary panel, the industry has urged it to woo back Indian scientists working with reputed global drug regulatory agencies of US and UK.
In a letter to union health minister Ghulam Nabi Azad, pharma sector captains through the auspices of industry body Assocham, have said, ?It is fortunate that a pool of Indian origin scientists populate the world?s leading regulators like US FDA (Food and Drug Administration) and UK MHRA (Medicines and Health products Regulatory Agency). These scientists must be attracted back to India? to create a world-class regulatory system.?
Pharma firms assert that China has adopted a similar strategy to strengthen its drug regulatory structure in a short span. At a time, when business has gone global, international exposure to best regulatory practices can make a substantial difference to the way of functioning of drug regulator?s office here.
At least in matters of global exposure, the industry urges government to model Drug Controller General of India?s (DCGI) office on the lines of the Reserve Bank of India, which it cites as an example of a mature regulator, that frequently sends its staff to be trained by the World Bank, helping its personnel gain international experience to regulate an increasingly borderless economic world.
Last week, Azad visited the US FDA headquarters and explored different options of collaborations with Indian drug regulator?s office.
The industry, however, questioned the panel?s recommendation to increase the minimum number of subjects in phase III pre-approval clinical trials to determine safety and efficacy of ?new drugs?, (a prerequisite for marketing approval of a drug) as well as its assertion that patients of different ethnicities (for instance mongoloids or dravidians) should be enrolled in these trials.
Drug firms feel at a time when research on medicines worldwide is undergoing a shift towards more personalised medicines targeting specific mutations or sub-types of cancer, it may not be possible to impose the mandate of including diverse ethnic groups in the trials.
?We are very concerned that the recommendation of the committee (parliamentary panel) regarding clinical trials in different ethnic groups? does not follow the global guidelines?? the letter said. Instead, they assert the focus should be on inclusion of important factors of gender and age in clinical trial subjects.
Further drug makers point out that they cannot force participation of subjects in clinical trials as practical limitations dictate in real world.
?…participation in clinical trials is a voluntary process, influenced by culture, education, convenience, personal beliefs and suspicions ? we cannot force participation. Trials are performed in communities where the disease is easiest to study (for instance) immunosuppressive drugs in transplant centers, anti-malarial drugs in Africa,? the letter said.
It also said ?the pharma industry was not consulted in the meetings of this committee (parliamentary standing committee) although it is impacted by the workings of CDSCO (DCGI?s office)?.
