Reacting to the extensive media criticism about the quality of drugs manufactured in India for exports, in the wake of the recent action against Ranbaxy by the US Department of Justice, the union commerce ministry has termed it as desperate attempts by other countries getting affected by the strength of Indian pharma industry.

“There are reasons to believe that vested interests are raking up isolated issues reported regarding technical deficiencies on manufacturing and GMP. India is enjoying a unique position of low cost manufacturing and highest quality medicine, best of both the worlds. 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 said.

Clarifying on reports of malpractices of pharma manufacturing in India, the ministry said the pharmaceutical sector 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. 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 viz. Tertiary, Secondary & Primary.

It further said that the Indian pharmaceutical 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. Indian pharmaceutical companies have huge manufacturing built in capacities hence able to meet time schedules. India has proven international quality standard capabilities as measured by number of ANDA approvals, DMF filings, US FDA/UK MHRA approved manufacturing facilities/bio equivalence centres, which are considered as key indicators for assessing the capabilities of any national pharma sector. This fact is further firmly demonstrated by the trends in the number of product approvals received from various major regulatory authorities of the world.

Regarding the actions taken by the government to ensure export of quality drugs, the ministry said that it has implemented the trace and track technology at tertiary and secondary level packaging. Steps are being taken to ensure the authentication process for trace and track.

Besides, the government of India has demonstrated its keenness to meet international requirements for exports of pharmaceutical products yet again by taking timely action for complying with the new procedural requirements of the European Union (EU) for import of Active Pharmaceutical Ingredients (APIs) into the EU. This landmark achievement underlines the seriousness the Government of India towards pharma exports.

And in due course of time, online application filing and tracking system would be evolved to bring in sufficient expediency and transparency in the entire supply chain, the ministry said.