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Drug manufacturing industry cries foul over poor regulation in India

09-Jan-15, The Economic Times

India's drug manufacturing industry is afflicted with poor regulation - a case of authorities not scaling up the supervisory process to match the pace of the sector's growth.

The botched up sterilisation surgeries in Chhattisgarh in November, which left 13 women dead, was a grim reminder about the need to increase oversight of both health practices in the country as well the manufacture of drugs by companies, some of which face increasing scrutiny for allegedly not adhering to global regulatory practices.

While drug makers say local regulators are ill-equipped and inadequately staffed to monitor them, the watchdogs in turn hold state governments responsible for failing to strengthen the supervisory mechanism."The governments were in a mad rush to attract investments by creating tax havens but did not pay enough attention to augment the scrutiny machinery.

As a result, drug regulators and manufacturers in very few states could attain respectable quality standards," a state drug controller told ET on condition of anonymity, admitting inadequacies in the system.

Both the central and state government are involved in granting approvals to drugs and their manufacture. However, drug controllers appointed by the state governments are hardly equipped with laboratories for quality controls and checks.

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