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State drug authorities working on different directions as chaos prevails over 294 FDCs
Ramesh Shankar, Mumbai | Monday, December 17, 2007, 08:00 Hrs  [IST]

Utter chaos prevails among the state drug controllers in the country over the implementation of the Drug Controller of General of India's (DCGI) directive to weed out irrational combination drugs from the market as they are working at cross purposes. While some are following the DCGI directive strictly, others are going by the stay orders issued by the Madras High Court. And some state drug controllers are literally sitting idle, neither wanting to antagonise the DCGI nor to displease the court.

That there is complete lack of clarity on the matter is crystal clear from the fact that while Haryana drug controller RL Sharma has reportedly given the green signal to the pharma companies to manufacture and market all the contentious 294 fixed dose combination (FDC) drugs, his counterpart in Andhra Pradesh RP Meena is strictly implementing the DCGI order, much to the chagrin of the pharma manufacturers in the state.

According to sources, the AP drug controller RP Sharma is strictly following the DCGI order on the plea that the court order is not bound on Andhra Pradesh as it is a decision by Madras high court which has jurisdiction only in Tamil Nadu. Apart from cancelling the manufacturing licenses of all the 294 FDC products, the drug authorities in AP are not allowing the traders to market these products. The AP drug department has reportedly confiscated drugs worth a whopping Rs 39 crore from the traders.

Sources said the manufacturers are not much affected in AP because among the Rs 39 crore confiscated by the drug department, hardly one crore of product is manufactured in AP and the rest has come from other states. Aggrieved over the action of the drug department, the state pharma associations and traders are meeting shortly to take stock of the situation prevailing in the state and also to work out future strategy.

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