The Indian pharmaceutical industry witnessed an alarming rise in the instances of document forgeries during the last six months. Growing instances of fake documentation in the areas of manufacturing and marketing approvals, quality certification for products and facilities and manipulations in R&D documents during the period indicate to a deteriorating regulatory system in the country.
Though there were few forgery cases reported in isolation in the recent past, there is a series of fake document instances during the last few months. The major one reported in the series was the multiple central approval letters faked by a Delhi-based racketeer to secure manufacturing licenses from Gujarat.
In the first week of June, the Food and Drug Control Administration (FDCA) Gujarat had unearthed this major racket that has been indulged in forging "new drug approval letters" for pharmaceutical companies. Based on the FIR filed by the state FDCA and the complaints from DCGI, the Gujarat Police arrested the prime suspect from Delhi and is zeroing in on other members including drug control officials, it is learnt.
The companies who have secured manufacturing licenses in the state using the fake central approval letters are Truecare Pharma, Reliance Formulations, Ronald Pharma, Bennet Pharma, Medoz Pharma, Brisco Laboratories and Depon Organics.
While the police investigation on the new drug approval racket is moving at the snail's pace, another major case of fake WHO GMP certificate came to light when Maharashtra Food and Drug Administration (FDA) confiscated the forged documents from the Mumbai-based Techno Drugs & Intermediates. The company forged the WHO GMP certificate by duplicating the signature of Commissioner, FDCA, Gujarat, for the registration of their products in Korea.
The Maharashtra FDA had also filed a similar case in January this year against the Palghar-based Medico Remedies for forging FDA clearance certificate for manufacturing certain products.
Currently, there is another case pending with the Maharashtra FDA in which one Raj Pharma has been accused of producing a fake GMP certificate for securing drug supply contract from the Armed Force.
Though most of the reported cases came to light following self initiative of certain state drug control departments, it is surprising to note that the office of Drug Controller General of India, the apex drug regulatory agency of the country, is still groping in darkness despite many other state departments remain inactive in such matters.
Interestingly, the states like Tamil Nadu and Delhi remain on top in having unauthorized drug licenses and illegal manufacturing facilities. While, pharma majors like Ranbaxy and Cipla entering in the WHO's black list with reportedly 'manipulated' clinical research data for their antiretroviral drugs.
According to industry sources, the increased support and aid from within the drug control departments in various states and the central department is one of the important factors, which helps proliferation of bogus certificates and documents in the drug industry.