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In the wake of the US drug regulator increasing its scrutiny of Indian manufacturing facilities, India too is planning to pull up its socks to strengthen its regulatory monitoring. According to sources here, the Central Drugs Standard Control Organisation (CDSCO) is mulling to significantly raise the number of drug inspectors across the country as well as establish drug testing laboratories at ports over the next few years.
A senior CDSCO official said, "The idea is to raise the bar for regulatory measures and standards here in India, and also closely monitor the quality of the shipments from India. The number of drug inspectors is likely to be doubled from the current crop of around 500 inspectors across the country. At the state level too, the number of inspectors would get a boost."
There are drug inspectors both at the Central and state levels. As many as 2,700 new drug inspectors could be deployed at the state levels.
HG Koshia, commissioner of the Food and Drug Control Administration (FDCA) of Gujarat said, "As far as the Central drug inspectors are concerned, the CDSCO peiodically raises the number as per requirement. Some are deployed at ports, while others at airports etc to monitor shipments." He added that as far as Gujarat was concerned, with the addition of new districts in Gujarat, the FDCA has already decided to ask for more drug inspectors at the state level. "We have around 150 drug inspectors here at the moment, and would ask for another 15 more to take care of the additional districts," Koshia said. Around seven new districts have been added in Gujarat in 2013, taking the total number of districts to 33.
The state is one of the key pharmaceutical manufacturing hubs in the country, and contributes over 25 per cent to the national pharmaceutical exports. As per sources in the know, apart from drug testing laboratories at the ports, some could also come up at airports across the country.
The Gujarat FDCA had launched a mobile drug testing laboratory in March 2013 for spurious drugs, which cost around Rs 67 lakh.
This was done to expedite the process detection of spurious drugs.
The CDSCO move assumes significance in the backdrop of the recent bans imposed by the USFDA on manufacturing sites in India. The FDA had recently banned four plants of Ranbaxy from exporting to the US, one plant of Sun Pharmaceuticals in Gujarat also came under the FDA scanner, apart from Wockhardt seeing two of its plants getting banned last year. Following the bans, FDA commissioner Margaret Hamburg had visited India earlier this year and met industry leaders as well as government representatives.
USFDA's new director in India, Altaf Ahmed Lal has been visiting different states across the country to take stock of the situation, as well as understand the issues faced by the industry on the quality compliance front. He was in Gujarat in March this year. USFDA too is working on capacity building of Indian exporters.
