The All India Drug Control Officers Confederation (AIDCOC) has approached the union health minister and the minister for state to take immediate steps to stop the government move to widen the scope of Central Licensing & Approval Authority by including the responsibility of issuing drug manufacturing licenses under its mandate.
The AIDCOC, in separate representations made to the ministers pointed out that sharing of responsibilities, or dual licensing system through CLAA is a failed experiment and is not at all practical in Indian context. The AIDCOC wanted the ministers to initiate "immediate steps for strengthening drug control organizations at central and state level and adopt a focused approach on the steps for curbing menace of spurious drugs rather than diverting the energy, time and resources on the issue of central licensing.
The confederation pointed out that all the four states, Punjab, Arunachal Pradesh, Manipur and Pondicherry, which favoured central licensing do not have much manufacturing activity in their regions. They felt that the recommendation of the Mashelkar committee came after brushing aside the opposition and reservations expressed by various professional bodies like Indian Drugs Manufacturers Association, Small Drugs Manufacturers Association, FDCA Gujarat Drugs Control Officers' Association and AIDCOC.
Pharmabiz had in July reported about the health ministry's move to expand the scope of the CLAA. Responding to the government move, AIDCOC secretary general S W Deshpande, had written to the health director pointing out the legal and logistical reasons that would make it impractical for the transfer of manufacturing licensing authority from the states to the centre.
The letter explained that, if the manufacturing activity was regulated by one agency and the sale and distribution by another agency, it could create logistic problems such as jurisdiction and co-ordination between the state and the Central Government. It may also affect speed and effectiveness of the investigation involving both traders and manufacturers, said the letter.
The letter argued about severe disparity in the number of drug inspectors and supervisory officers with CDSCO, which is far less compared to that of the state departments.