The government and the industry are working on a 'trace and track' mechanism, which would enable monitoring of the pharmaceutical supply chain at all the three levels, viz, tertiary, secondary and primary, so as to rid the industry of spurious and sub-standard products, the commerce ministry said today.
The ministry said the initiative follows extensive negative reporting in the print as well as electronic media about the quality of drugs (pharmaceutical products like APIs 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.
''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 commerce ministry said in a statement issued today.
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, the ministry said in the release.
Indian pharmaceutical industry is a highly knowledge based industry with a huge manufacturing base, which is growing steadily and playing a major role in the Indian economy. India also has a large vendor base for supplying quality generics/API/ contract manufacturing with state of the art facilities, the ministry pointed out.
''India has proven international quality standard capabilities as measured by number of ANDA approvals, DMF filings, USFDA/UK MHRA approved manufacturing facilities/ bio equivalence centers, 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,'' the statement added.
Quoting statistics from Pharmexcil that indicate the strong presence of Indian industry in the US, the ministry pointed out that the reports of US FDA penalising Indian companies are only a small aberration.
As per Pharmaexcil data:
- India had over 3,000 drug master filings (DMF's) with the US (filed by 233 Indian companies), amounting to almost 40 per cent of the total DMF's filed With USFDA as of 30 December 2012.
- During the year 2012 USFDA granted 476 abbreviated new drug application (ANDAS) for generic drugs and India has 178 market authorisations of them, ie, 37.4 per cent of the total.
- Over 2,275 ANDAs are approved by USFDA covering over 31 different companies as of 30 December 2012.
- There are over 550 manufacturing sites registered with USFDA, out of Which 323 sites are approved by USFDA as of 31 March 2013.
- 130 companies have over 902 Certificate of suitability of monographs of the European Pharmacopoeia (CEPs) approved by European Directorate for the Quality of Medicines and Healthcare (EDQM), which is more than 25 per cent of the total CEPs approved by EDQM globally.
- 27 per cent of the formulations are exported to USA and India has a share of 15 per cent of US generics by way of volume.
In India, there are more than 350 manufacturing sites endorsed by EU for their GMP as of 30 April 2013. All these speak about India's ability to harness large talent pool to produce quality pharmaceuticals - second to none in quality, that too at the most competitive prices.
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.
Salient features of India's pharmaceutical exports:
- 4th in the world in terms of production volumes
- 13th in domestic consumption
- 12th in terms of export value of bulk actives and dosage forms
- Over 55% exports of India are to highly regulated markets.
- USA the largest exports destination followed by UK.
- Largest exporter of formulations in terms of volume with 14% market share.
The increase in exports over the last few years indicates the growing strength of pharma industry.
India's export of pharmaceutical products has steadily grown by 14.86 per cent to $8789 million in 2008-09, by 2.08 per cent to $8,971 million in 2009-10, by 19.51 per cent to $10,722 million in 2010-11, by 22.78 per cent to $13,165 million in 2011-12 and further by 10.55 per cent to $14,590 in 2012-13.