Drug inspectors hard-pressed to scrutinise factories

Apr 08 2014, 13:27 IST
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SummaryA drugs regulator is among the first to ad mit that oversight of Indias huge pharmaceutical industry can be patchy.

continue to make and sell medicines, three state drug regulators told Reuters.

About 40% of generic and over-the-counter medicines sold in the United States come from India, where they are made in over 500 plants that are subject to inspection by the FDA. The US regulator, guardian of the world's most important pharmaceuticals market, has over the past year imposed import bans on plants run by Ranbaxy Laboratories, Wockhardt Ltd (WCKH.NS) and Sun Pharmaceutical Industries Ltd (SUN.NS).

The remaining 10,000 plants fall under the watch of India's inspectors.

Plants barred from shipping to the United States typically continue making drugs sold elsewhere, industry analysts say.

Ranbaxy and Wockhardt declined to comment. The Sun Pharmaceuticals plant only made drugs for the US market. How come it is the FDA who has picked up this problem and not the Indian agency? said Christophe Perrin, pharmaceutical coordinator with Mdecins Sans Frontiers, a non-profit that advocates for access to generic drugs of the sort made in India.

The Indian agency should be on top of these things.

The FDA, itself, is scrambling to add staff in India to meet a requirement that overseas plants face the same level of scrutiny as those in the United States.

Responding to criticism about the standard of medicines made by domestic firms, the health ministry last month issued a statement defending the regulator, saying a "robust regulatory framework" ensures high standards of quality, safety and efficacy.

Under law, states regulate the manufacture, sale and distribution of drugs, while central authorities handle approvals of new drugs and clinical trials, oversee drug imports and coordinate the activities of the state regulators.

Except for the US, other countries have no problems with our drugs. They have never raised any objections or have found fault, said a health ministry official, requesting anonymity because he was not authorised to speak to the media.

In fact, last year Britain's drug regulator imposed import curbs on two Wockhardt plants.

The Drug Controller General, GN Singh, said the regulator tried its best to make sure drugs were regulated efficiently. "Things are moving forward," said Singh, who is responsible for granting licences to manufacture medicines. If Haryana's regulator is telling you he is not able to regulate drugs properly, he must be right. The state governments are responsible for that, not the CDSCO (Central Drugs Standard Control Organisation), he said.

Indian companies have rushed to cash in on the rampant growth of generic pharmaceuticals in the past decade, as

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