The government, on Monday, said the quality of drugs produced by the pharma industry was of proven global standards and the sector was a highly regulated one.
“The pharmaceutical sector is a highly regulated one, and the exports are heavily guided by various regulatory regimes of the importing countries...,” the Commerce and Industry Ministry said in a statement.
India has proven global quality standard capabilities as measured by number of Abbreviated New Drug Application (ANDA) approvals, DMF (drug master file) filings, USFDA/U.K. MHRA (Medicines and Healthcare Products Regulatory Agency) approved manufacturing facilities/bio equivalence centres, which are considered as key indicators for assessing the capabilities of any national pharma sector, it added.
“This fact is further firmly demonstrated by the trends in the number of product approvals received from various major regulatory authorities of the world,” it said.
All the organisations concerned in the government are constantly interacting to ensure that India’s image as a safe exporter is protected. The government and the industry are already working on a ‘trace and track’ mechanism, which would enable monitoring of the supply-chain possible at all the three levels, namely, tertiary, secondary and primary, the statement said.
In such a situation, the reports of the U.S. Food and Drug Administration (USFDA) penalising Indian companies are only a small aberration, it added.
The government’s reaction came as there were reports about an India-based pharma firm pleading guilty to felony charges relating to manufacture and distribution of certain adulterated drugs made at two India units, and the company agreed to pay $500 million — the largest settlement with a generic medicine maker till date.
India enjoys a unique position of low-cost manufacturing and highest quality medicine. The government also believes that some of the spurious drugs detected in the international markets, allegedly exported from India, are desperate attempts by other countries getting affected by the strength of the Indian pharma industry, the statement said.
There are more than 350 manufacturing sites endorsed by the European Union (EU) for their good manufacturing practice in India as on April 30, 2013.
The government has taken a number of steps to ensure manufacture and export of quality drugs, which include the trace and track technology mandate at tertiary and secondary levels.