India lose USD 1.3 billion to USFDA ban: Pharmexcil

India lose USD 1.3 billion to USFDA ban: Pharmexcil

DrugsNew Delhi (ISJ): India lost about 1.3 billion USD worth export of pharmaceutical products during the current financial year as a fall-out of US ban on import of drugs from certain pharma majors, said apex pharma export body. Pharmaceuticals Export Promotion Council of India (Pharmexcil) said exports registered an overall growth of 1.5 per cent during the current fiscal, as against 10.5 per cent during fiscal 2012-13.

US Food and Drug Administration (USFDA) had barred import of drugs manufactured by Wockhardt Laboratories, Ranbaxy Laboratories and Sun Pharma from some of its plants in India for not adhering to quality standards and regulatory mechanism. India is the largest supplier of generic medicines to the US; close to 40 per cent of generic and over-the-counter medicines sold in the United States are imported from India.

Addressing a news conference in New Delhi, Pharmexil?s Director General Dr. P.V. Appaji said, following USFDA?s demand for plant audits of pharmaceutical manufacturers, even small African countries are now seeking a similar exercise, before approving Indian imports. He said the US regulations have stifled Indian pharma exports in the recent times.

New Delhi, however, rejected the charge and claimed, drugs manufactured India meets global quality standards. ?Quality was not an issue, per se,? but ?documentation and data integrity issues,? said Sudhanshu Pandey, Joint Secretary in the Central Ministry of Commerce and Industry.

The national drug regulator ? Central Drugs Standard Control Organisation claimed a national survey found only 0.046% (11 out of 24,136 samples) spurious drugs and blamed the media for creating a hype over the issue. The report further says, the extent of substandard drugs among branded products are only 0.1% (03 out of 2976 samples), which do not conform to Assay on chemical analysis. The ?latest? report however, pertains to 2009.


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