The Drugs Controller General of India (DCGI) will inspect overseas manufacturing units before allowing companies to import drugs from these facilities. Inspectors will travel abroad to make sure that the companies were adhering to standard industry practices to ensure safe drugs imports.
This is the first time that India has decided to inspect manufacturing facilities in other countries, despite having provisions in the Drugs and Cosmetics Act. Countries who buy drugs from India, however, inspect the onshore facilities before allowing imports.
“We are awaiting an approval from the Centre to send out drug inspectors to audit the manufacturing facilities abroad,” said Surinder Singh, DCGI, while addressing the media at a national seminar organised by the Bulk Drug Manufacturers Association of India.
This year, the pharma regulator had cancelled 104 import licences citing quality issues, he said.
India imports bulk drugs from China and Italy, among other countries, worth Rs 12,000 crore every year. The pharma industry in the country is now valued at Rs 1,00,000 crore and exports are valued at Rs 42,000 crore.
Among others, DCGI will increase pharmacovigilance, particularly on nimesulide, an anti-inflammatory drug, and seven other drugs. It would bring 40 medical colleges under this ambit and cover all the 300-plus colleges in two years. It would also rope in private hospitals for pharmacovigilance to generate its own data about side effects of drugs and reduce the dependence on the data emanating from the US and other countries.
The DCGI has also decided to introduce mobile drug testing vans for random testing of medicines. It tests about 40,000 samples at present and is targeting to increase this to 2,00,000 by introducing mobile units, that would cost about Rs 4 crore each.
“More than spurious drugs, dealing with sub-standard drugs are a challenge for the DCGI. Of the samples tested, about 0.01 per cent turns out to be spurious but nearly 6 per cent of them do not have the standard quality,” he added.
DCGI will be issuing guidelines for regulation of clinical trials ethics committee and for sites where such trials would be conducted. It plans to divide the country into zones to carry out audits at all sites where trials are being conducted.
“It is only a hype that India is turning into a hub for clinical trials. Currently, only 1-2 per cent of the global clinical trials are being done here as compared with 50 of the global trials by the US,” he said, adding according to the new guidelines all clinical research organisations would have to register their clinical trials with DCGI. At present, 1,250 trials are being carried out in India.
DCGI had recently increased the number of drug inspectors to 74 and would add another 95 to take the strength to 169, said Singh.
With respect to acquisitions of domestic pharma companies by multinational giants, he said it was a larger issue that called for coordination from various ministries. There was a need to work out a long-term strategy to strengthen the domestic industry and to ensure affordable drugs. An overhaul of the present Drugs and Cosmetics Act was also needed, said Singh.
