The Drugs Control General of India (DCGI) will implement a series of measures to make the drugs control department more effective in operation and also to make drugs control department transparent and accountable.  

The immediate measures would include the overseas inspection of sites, strengthening of infrastructure and hiring of personnel, enforcement of drug sampling, monitoring of clinical trials ethics committee and the sites of human studies and keeping a close watch on the fatal incidents and adverse drug reactions.

DCGI Dr Surinder Singh, who was in Bangalore for the one-day seminar  on 'Pharmacovigilance in India' told media persons on the sidelines of the event that drugs control operations in the country will now be more transparent, accountable and efficient, making the system faster and easily accessible. The seminar was organized by the  Indian Pharmaceutical  Association Karnataka  branch, Regulatory Affairs Division, IPA Centre Mumbai, and Karnataka Drugs & Pharmaceuticals  Manufacturers  Association (KDPMA).

Come March, the India’s team of enforcement officers would gear up for its maiden overseas inspection at sites in China and Italy.  This will be on similar lines of the international regulatory inspection visits.  Currently the interpreters  and visas are being sought. On March 16, enforcement officers would embark on this process and will visit China to carry out inspection of 10 sites.   A few months ago, 10 registrations comprising of 105 imports have been  cancelled.  With China and Italy accounting for 70 percent of the bulk imports, there is a need to assess the  quality and good manufacturing practices of the international plants.

Another initiative that is coming out of the DCGI Office is the enforcements  on drug sampling. While there is a need to increase number of drugs to be brought in for tests from the current 60 to 4,000 across the country, there is also the need for modernization and increasing the number of drug test. The regulator has now selected six  out of the 22 National Accreditation Board for Testing and Calibration Laboratories which will help speed up analysis and reports.

On the clinical trials front,  DCGI said  India has a long way to go in the field of human studies. Of the one lakh trials carried out globally, US accounted for 52,000 and India conducted only 15,000 studies. There has been a lot of hype that the country is the hub of clinical trials and that its patients were guinea pigs for drug assessment. In order to create more transparency, monitoring of ethics committee and the trials sites would soon be on the drug regulator’s radar. The violators would warrant action under the Indian Penal Code and Drugs & Cosmetics Act, he said.

The department is being spruced to increase the level of efficiency  with the networking of 11 port offices, 6 zonal offices, 3 sub zonal offices at Bangalore, Jammu and Chandigarh besides six drug test labs being linked with video conferencing. This would  help industry and regulators track the status of the product dispatched and the applications.

There has been an acute shortage of personnel including inspectors. We are on an aggressive hiring mode by strengthening the department people to 918. Currently 636 posts are under approval and would look at increasing the number by another 327 over the next 12-16 months.  There are also several openings in the Central drugs Standard Control Organization (CDSCO) where candidates from the state  drugs control departments can apply for many of  these posts, he  said.