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Ranbaxy withdrawal of drugs worries Health Ministry

Nithya Subramanian

New Delhi , Nov. 10

FOLLOWING Ranbaxy Laboratories' decision to withdraw all its anti-retroviral (ARV) drugs from the World Health Organisation (WHO) list, the Health Ministry is concerned about this development and is likely to ask the Drugs Controller General of India (DCGI) to look into the issue.

Senior officials in the Health Ministry said, "We are concerned especially after Ranbaxy's recent move to voluntarily withdraw its ARVs. Earlier, it was WHO which had dropped the drugs. This time, the company has done so on its own. We may ask DCGI to look into the issue."

Currently, WHO is the procurement agency for the free ARV programme under the National AIDS Control Organisation (NACO) and buys the drugs from various manufacturers.

Officials said even if WHO decided not to buy drugs from Ranbaxy for the time being for domestic use, it could do so from other companies such as Torrent or Hetero, which also manufacture ARVs.

Meanwhile, officials at NACO said the situation was being examined and a decision would be taken soon.

Only on Tuesday Ranbaxy informed WHO that it was voluntarily withdrawing all its ARVs (all the product dossiers under assessment and all pre-qualified products) after it found discrepancies in the documentation relating to proof of the products' bioequivalence with originator medicines.

The company has presented a plan to WHO indicating the proposed dates for the submission of new study reports for these products. The first study is expected to be complete by December. Dr N. Kumarsamy, Chief Medical Officer and Clinical Researcher of YRG Care (a non-profit organisation dedicated to HIV/AIDS), said, "Once drugs are dropped from the WHO list, other countries or organisations will not be able to procure from them."

According to industry analysts, Ranbaxy's ARV business could temporarily take a hit of Rs 30-50 crore. "Ranbaxy had only recently decided to pull out of the South Africa market. Its deal with the Clinton Foundation whereby it was to supply cheap ARVs along with Cipla and Hetero to South Africa could also be impacted," they said.

However, some others believe the voluntary withdrawal of drugs is a precautionary measure by the company.

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