The Economics Times
27 July 2009
New Delhi, India
By Sushmi Dey

The ministry of health seeks to introduce a quality mark for the Rs 35,000–crore generic drugs market to enable consumers distinguish between quality and sub–standard medicines. A generic drug is not protected by patents and can be manufactured without paying royalty.

The country’s drug regulator, Drugs Controller General of India (DCGI), had recently collected 24,600 samples under 62 brands across nine product categories to identify spurious and sub–standard drugs. The quality mark for drugs–which is likely to be based on the ISI mark for manufactured products and Agmark for food products–will check the hazard posed by these harmful medicines.

“We are working on a draft proposal to introduce a provision in the Drugs and Cosmetics Act (DCA) to have a quality mark on generic drugs. This is a part of the effort that we are constantly making to monitor the quality of drugs manufactured and sold in the country,” a health ministry official told ET on condition of anonymity.

While central and state drug inspectors monitor the sale of medicines in the market, a quality logo on generic medicines would help a consumer identify genuine medicines.However, some industry experts say that there is a greater need to strengthen the regulatory regime to prevent manufacturing of spurious medicines.

“The government must first address the need for more inspections of manufacturing units and see that the production units comply with the good manufacturing norms. If the units fall short of such norms, there should be a political will to take action against them,” said D G Shah, secretary general of the Indian Pharmaceutical Alliance.

The idea of introducing a quality mark for generic medicines was mooted by the Pronab Sen Committee as a number of small–scale pharmaceutical units have started manufacturing such drugs. The idea was also supported by the Planning Commission in its recommendations for the 11th Five–Year Plan that ends in 2012.