The All India Drugs Control Officers Confederation (ADICOC) has asked the Drug Controller General of India (DCGI) to clear the air over the decision to withdraw the manufacturing licenses of irrational drug combinations. It has asked the DCGI to clarify which are the combinations that are irrational, combinations with semi-therapeutic use, combinations that do not have any therapeutic use and irregular combinations.

According to AIDCOC, currently there is stalemate over the whole issue. There is lot of confusion prevails among the regulators in the state, the industry, and the consumers as none is sure about the proposed action.

"Unless and until the irrational combinations are covered under section 26A of the Act and the DCGI specify the combinations which are not valid, there will not be any use of withdrawing the licenses of such combinations," Ravi Uday Bhaskar, general secretary of the confederation told Pharmabiz.

Talking about the Central move he said, "As only section 26A of the Drugs and Cosmetics Act, 1940, empowers DCGI to cancel licenses of such formulation throughout the country, except that there is no other provision that validates the DCGI on the issue. If any manufacturer approaches court against the DCGI order, he will have to defend the same. The DCGI should decide as to how many of the 1045 odd combinations are irrational, semi-therapeutic and not useful and mention them under section 26A of the Act," he said.

"Lot of NGOs, consumer welfare bodies and other interested parties are posting us queries with regard to irrational combinations. We are unable to answer them as the list also contains certain combination which do not have any use," he added.

The issue was also discussed in one of the recently held ADICOC meetings wherein drug control officers were of the opinion that the DCGI should sort out the issue on priority basis. "How long the DCGI is continuing to maintain silence in this matter?" questions the general secretary of the confederation.

Meanwhile, the ADICOC held its election in Ahmedabad on July 28, wherein K Ravi Kanth from Delhi was elected as president of the confederation, Ravi Uday Bhaskar was re-elected as the general secretary for 2007-09. Two other officers from Andhra Pradesh, G Dharma Data and K Raja Bhanu were elected as secretary and vice-president respectively. Nine vice-presidents, ten secretaries and other administrative staff were also elected.