Clarifications on Reports of Malpractices of Pharma Manufacturing in India

1.         There have been extensive media reporting in the print as well as electronic about on 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

2.         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 organizations 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.

3.            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, 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.

4.         The following statistics reported by Pharmexcil indicates the strong presence of Indian industry in the US and the reports of US FDA penalizing Indian companies are only a small aberration:

• India had as on 30th December 2012 over 3000 Drug master filings (DMF’s) with USA amounting to aalmost 40% of the total DMF’s filed With USFDA. These are filed by over 233 different companies from India.
• During the year 2012 USFDA has granted 476 ANDAS and India has 178 market authorizations of them i.e. amounting to 37.4% of the total.
• As on 30th Dec 2012over 2275 ANDA’s (Abbreviated new drug application)(Generics) 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 31st March 2013.
• 130 companies have over 902 CEP’s approved by EDQM, which is more than 25% of the total CEP’s approved by EDQM globally.
• 27% of the formulations are exported to USA and India has a share of 15% of US generics by way of volume.

5.         There are more than 350 manufacturing sites endorsed by EU for their GMP in India as on 30th April 2013.  All the facts quoted above speak about India’s ability to harness large talent pool to produce quality pharmaceuticals – second to none in quality and 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 Indianpharma industry.

• Salient features of export trends:
• 4th in the world in terms of production volumes
• 13^th in domestic consumption
• 12^th 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:

 Indian regulatory system

6.       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 meeting 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.

7.         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.

Recent Actions taken by GoI to ensure export of quality drugs

• The trace and track technology mandate at tertiary and secondary level stands implemented. Date of primary level packaging is postponed to 1.7.2014.   Steps being taken to ensure the authentication process for trace and track under way.  DoC in talk with Health& FW in the matter seeking common approach for both exports and domestic tracking.
  • 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.

• 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.