ASSOCHAM has suggested setting up of a `National Commission on Eliminating Menace of Spurious Drugs’ to ensure that unorganised pharma companies stop their manufacturing and India gets out  of it’s bad reputation as `a Hub of Fake Drugs’ in markets of US and EU

The spurious drug market is growing due to lack of efficiently functioning government testing laboratories, non-availability of adequate and trained manpower, weak laws and low penalties, besides archaic procurement norms and little implementation of existing laws. As a consequence the unorganised pharma sector has been responsible for putting India’s reputation at stake by producing fake and counterfeit medicines.  The menace since go uncurbed, it often results in supplying of sub-standard drugs into large number of central government dispensaries, armed force medical institutions and health institutions belonging to railways, municipal corporation and many other local governments.

According to ASSOCHAM, about 10% of drugs globally are spurious and sub-standard which in terms of figures nearly amount to US$ 60 billion. India’s contribution to this global spurious trade is just miniscule in nature given the fact that its pharma exports are rising at substantial pace.  India’s rising exports, the food and drugs administration has approved about 100 pharma plans in India for manufacturing quality drugs.  Countries like China and Italy have 27 and 55 FDA approved plants. 

The setting up of commission will help in removing India from the 'Watch List' of US and European Union for the import of pharmaceutical products from India. According to Assocham, it  is very unfortunate that despite that the country has highest number of USFDA approved plants outside US, the latter's administration has kept India under 301 watch list to monitor its pharma exports. The setting up of the commission is also very important as exports from the country are increasing rapidly and bad reputation in terms of spurious drug may harm the growing export of drugs from the country, the chamber said. The spurious drug market has been growing in the country due to lack of efficient government laboratories, non-availability of trained manpower, weak laws and lower implementation of existing laws, the statement further added. The suggested commission should check the sample of genuineness of packaging with the company in whose name it is sold as also check the ingredients for quality composition. 

Indian pharma industry is expanding and therefore it is recommended that a National Commission on Eliminating the Spurious Drugs should be set up as early as possible to counter with evidence the fakeness in domestic drug manufacturer as presently, there is no such authority in India.

The Commission should be empowered to ensure strict implementation of the recommendations that the Health Ministry is proposing to enforce through an Act of the parliament.  It should be ideally headed by a retired High Court Judge, ably assisted by a senior bureaucrat, preferably with necessary experience with Ministry of Chemicals & Petrochemicals.