INDIA BUSINESS WORLD - DECEMBER 1st - DECEMBER 15th
- 2007
MADRAS HIGH COURT STAYS DRUG COMBO BAN
In yet another reversal for the government, the Madras High Court (HC) has stayed the government's notification to force state drug regulators to weed out combinations drugs from the market.
The drug controller general of India (DCGI) M Venkateshwarlu had on November 28 issued notices using section 33 (P) of the D&CA to the state licensing authorities (SLA) and union territories to comply with its directions to phase out drugs from the retail market. It was earlier reported that DCGI was using the provision to make its directions 'statutory' rather than 'advisory', as DCGI felt that state regulators were not effectively implementing its directions.
The Confederation of Indian Pharmaceutical Industry (CIPI), which represents around 3,000 small drug manufacturers had moved the Madras HC against the government's notification to use the special clause of the drugs act. These drugs are marketed by leading manufacturers totalling about 1,067 brands estimated to be worth around Rs 3,500 crore. CIPI has already received a stay order against the government's order to suspend the manufacturing licenses of these drugs. This is the fourth stay order against the government's plans to phase out the contentious 294 combination drugs.
The DCGI was not available for comment. However Mr. Venkateshwarlu had earlier said he may even move the Supreme Court if it received reversals to its orders.
CIPI chairman TS Jaishankar said, "Instead of revoking the order after we got a stay against DCGI earlier order, the government took a new route through 33(P) to create pressure on SLAs to stop sale of drugs. It is unfortunate but we had to move the court as a precautionary measure and avoid any confusion."
Meanwhile, DCGI has approved six drug combinations drugs of dextropropoxyphene, following a representation by few drug manufacturers. The industry has also alleged that the government was selectively approving combinations. "These six drugs were changed to 'banned' drugs category from 'rejected' category in October 31. However, DCGI has now approved the drugs even as the company's representation is with the drug technical advisory board for a review," a company executive said.
The market size of these drugs segment is around Rs 100 crore and is dominated by Wockhardt.
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