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Times of India
05 November 2011
By Kounteya Sinha
New Delhi India

How many times have you taken a medicine and felt it hasn’t worked at all? It could have been a sub-standard drug.

The Union health ministry says around 5% of drugs in India’s Rs 1,00,000 crore pharmaceutical industry are sub-par drugs. At a conservative estimate, drugs worth about Rs 5,000 crore could be sub–standard — popping them would not have an optimum effect.

Alarmed, the drug controller general’s office has decided to put in place proper guidelines on what needs to be done when the quality of drug is found to be sub–standard through lab tests, and by when they need to be taken off the shelves at retail outlets. A meeting of all state drug controllers has been called on November 14, which would discuss ways to combat India’s growing problem of sub–standard drugs and to put in place a three–member committee to finalize the guidelines.

A ministry official said, “Now, once a lab in Maharashtra confirms that a batch of drugs found in Delhi is of substandard quality, nobody knows who should take action and what it should be. In reality, such drugs need to be taken off the shelf as soon as they are found sub–standard before they reach the consumers who won’t benefit from them. The guidelines will specify the action for all state drug controllers and also for the first time quantify within how much time the sub–standard drug needs to be taken off the shelves of all retail outlets.”

Drugs of poor quality — both irrational and sub–standard drugs — flooding Indian market has been a serious concern even in the Planning Commission. A committee of the commission, headed by Dr K Srinath Reddy, said the pharmaceutical industry spent over 25% of their annual turnover on promotion alone as compared to a paltry 7% on research and development in 2008–09.

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