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Govt. rejects allegations of exporting counterfeit drugs

India Monday rejected allegations of exporting counterfeit drugs, saying those are desperate attempts by some countries to malign its flourishing pharmaceutical industry, which enjoys a unique position of low-cost manufacturing and highest quality medicine.

It said there were reasons to believe that "vested interests" were raking up isolated issues about technical deficiencies in good manufacturing practices (GMP). There have been extensive media reporting about on the quality of drugs (pharmaceutical products like Active Pharmaceutical Ingredients and formulations) manufactured in India for exports.

Some isolated reports have also been received about export of spurious /counterfeit drugs attributed to some source in India.

"Government has strong reason to believe that some of the spurious drugs detected in the international markets, alleged to be exported from India, are desperate attempts by other countries getting affected by the strength of Indian pharma industry," the ministry of commerce and industry said in a statement to clarify on reports of malpractices of pharma manufacturing in India.

The statement came after New Delhi-based Ranbaxy Laboratories, India's largest drug company by sales, pleaded guilty in the United States to criminal charges of making adulterated medicines and agreed to a 500 million dollar (around Rs.2,833 crore) settlement.

The ministry said the pharmaceutical sector in the country is a highly regulated one and the exports are heavily guided by various regulatory regimes of the importing countries. And there is also a requirement for continuous monitoring of quality related aspects, including complaints of sub-standard / falsified drugs from various countries.

The Drugs Controller General of India (DCGI) is responsible for approval of licenses of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India. The State Drug administration offices regulate issue the manufacturing licenses and quality control monitoring etc.

The DCGI regularly holds meetings with the State authorities and also interacts with drug regulators across the globe to ensure that the international practices of manufacture and supply of drugs are followed in India. India's compliance with TRIPS and consequent implementation of Patents Act is appreciated all over the world.

"All the concerned organisations in the government are constantly interacting to ensure that India's image as a safe exporter is protected from all angles. Government and the industry is already working on a 'trace and track' mechanism which would enable monitoring of the supply chain possible at all the three levels -- tertiary, secondary and primary."

The pharma industry is a highly knowledge based industry which is growing steadily and playing a major role in the Indian economy. India has a large vendor base for supplying quality generics/API/ contract manufacturing with state of the art facilities.

The ministry said there are more than 350 manufacturing sites endorsed by EU for their GMP standards in India as on April 30, 2013. As on December 30, 2012, over 3,000 drug master filings (DMFs) with the US, amounting for an almost 40 percent of the total DMFs filed With the USFDA, are filed by over 233 different companies from India.

"Companies/importers from all over the globe are encouraged to visit the manufacturing facility in India to satisfy themselves of the quality of production of drugs," the government said.

India's pharma industry is 4th in the world in terms of production volumes and over 55 percent exports are to highly regulated markets.

India's drug exports totalled $14.6 billion (around Rs.82,730 crore) in the financial year up to March 31, marking growth of nearly 11 percent from the previous financial year.