With the aim to start inspections of drug manufacturing facilities in countries from where India imports drugs, the Drugs Controller General of India (DCGI) is all set to increase the number of drug inspectors in the country from the current 864.
Surinder Singh, Drugs Controller General of India, said, "Currently there are 1364 sanctioned posts, and around 864 are filled up. We need at least 3,100 drug inspectors in the country." He added that there are around six lakh chemists and druggists in the country, and the bare minimum requirement is to have at least 3,100 inspectors, and this is a long term strategy for the DCGI.
Moreover, the drug regulator of the country is also taking initiative to send inspectors to those countries from where India imports drugs to check and certify manufacturing facilities and production quality of the pharmaceutical products.
India imports drugs, active pharmaceutical ingredients (APIs) and pharmaceutical intermediates from countries like China,Taiwan and Italy. The decision to inspect onshore facilities has come in at a time when the DCGI had to cancel over 100 import licenses this year. Import volumes are approximately pegged at around Rs 12,000-13,000 crore per year. This is much lower compared to the country's exports though, which is pegged at around Rs 42,000 crore.
While India has been lenient about inspecting onshore drug manufacturing facilities, most other countries currently importing pharmaceutical products from India do periodical inspections to certify the production sites here.
India has around 100 pharma manufacturing facilities approved by the US Food and Drugs Administration (USFDA), the largest number of facilities outside the US. And, USFDA conducts strict inspections from time to time to give nod to importing drugs from a particular facility ensuring that it follows the good manufacturing practice (GMP) standards set by the Federal regulator.
Recenlty, the US drug regulator had sent show cause notice to an Ahmedabad based injectable major, Claris Pharmaceuticals Ltd. Several such notices have been sent out to other majors including Ranbaxy, Wockhardt, Sun Pharma, Lupin Cipla in the past.