MNC-units-abroad-to-come-under-drug-regulator-scannerThe Drugs Controller-General of India (DGCI) will soon start sending its officers to foreign countries to inspect the manufacturing facilities of multinational pharmaceutical companies importing drugs into India. The move is in line with the processes followed by the drug regulators of other countries.

Dr Surinder Singh, DGCI, said, “Inspectors from other countries, from Nepal to the US, come to India to check manufacturing facilities of Indian drug companies. We also get drugs imported from many countries such as Taiwan and China for which we will start sending our inspectors to examine whether they are following good manufacturing practices.”

According to the DGCI, drugs worth Rs 1,500 crore were imported into India in 2007-08.

A number of Indian pharmaceutical manufacturers have had to run into rough weather with foreign drug authorities. Recently, the USFDA banned drugs being manufactured by Ranbaxy at its Paonta Sahib facility for not following set procedures. Once the Indian drug regulator starts investigating foreign facilities, then multinational firms will also come under the scanner.

Dr Singh, who was recently chosen as the eighth most influential person in the global pharmaceutical industry, said that the entire focus of the DGCI was to bring in more transparency to the processes being followed by the drug regulator.

Using IT

“We are using IT for changing the way we work. We are undertaking a massive e-governance project, which will allow pharma companies to do everything from submitting their applications to getting licences from us online. This project will be implemented in three years,” Dr Singh said.

The DGCI has roped in the New York-based IT firm MGRM to work out the implementation roadmap.

The DGCI is linking up all its zonal offices, which will enable pharma companies to monitor the status of their applications online in real time.

“India is fast becoming the global hub for the pharmaceutical industry. Therefore, we must have systems in place that will enable us to give the best services without compromising on the quality and standards,” Dr Singh said.

CRO registration

The DGCI will also enforce mandatory registration and audit of CROs or clinical research organisations post-June this year.
Details of the clinical trials they conduct across the country are to be brought into the public domain.

Dr Singh said that CROs were mushrooming all over, with nearly 700 trials for drugs, vaccines and medical devices taking place in the country.

“Issues of credibility, quality and reliability of these trials are weighing on our mind and the measures would raise the benchmark for trials done in India.”