Few isolated cases cannot undermine well regulated system, says commerce ministry
The Indian government appears to be keen to protect the reputation of the Indian pharma industry, which has been dented by the recent incident of Ranbaxy pleading guilty to selling sub-standard drugs in the US. In a press release issued on Monday, the department of commerce under the Union Ministry of Commerce and Industry said the Indian pharma industry is well regulated and that it could not be undermined because of a few isolated cases.
| Indian pharma's success story
- India had, as on December 30, 2012, over 3,000 drug master filings (DMF’s) with USA amounting to almost 40 per cent of the total DMF’s filed with USFDA. These are filed by over 233 different companies from India
- During 2012, USFDA has granted 476 ANDAS (abbreviated new drug application, generics) and India has 178 market authorisations of them—amounting to 37.4 per cent of the total
- As on Dec 30, 2012, over 2,275 ANDAs are approved by USFDA, covering over 31 different companies
- There are over 550 manufacturing sites registered with USFDA, out of which 323 sites are approved by USFDA as on March 31, 2013
- 130 companies have over 902 CEP’s (Certificate of Suitability to the monographs of the European Pharmacopoeia) approved by EDQM (European Directorate for the Quality of Medicines and Healthcare), which is more than 25 per cent of the total CEP’s approved by EDQM globally
- India has a share of 15 per cent of US generics by way of volume
It was referring to the Ranbaxy case
in which the country’s biggest generic medicine manufacturer agreed to pay $500 million to settle civil and criminal cases relating to selling sub-standard drugs and submitting false data to the US health authorities.
The press release said pharma exports from India are heavily guided by various regulatory regimes of importing countries and there is also continuous monitoring of quality-related aspects, including complaints of sub-standard/falsified drugs from various countries.
'Vested interests harming India'
The ministry further said that vested interests are working to damage the image of Indian Industry. “There are more than 350 manufacturing sites endorsed by the EU for their GMP (good manufacturing practices) in India as on April 30, 2013.
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,” the statement read.
The press release cited facts to establish the success story of Indian pharma industry (see box), and said the ministry 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.
Referring to statistics reported by Pharmexcil, the government said that the strong presence of Indian industry in the US and the reports of US FDA penalising Indian companies are only a small aberration:
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