The Parliamentary Standing Committee on Health & Family Welfare, which is examining the issues involved in creating the Central Drug Authority of India and the mandatory registration of the clinics, took the views of SME Pharma Industries Confederation (SPIC) and the Indian Medical Association at the sitting for the North India here recently.
Though the panel, headed by Amar Singh, held the sitting on January 25 to listen to the suggestions and complaints of interested players in the North India, only a few turned up. Panel sources also refused to divulge details of the sitting before drafting the recommendations.
However, it is learnt that the panel was briefed about the woes faced by the small scale pharma industry and conveyed the apprehensions about another mechanism to monitor the sector.
Besides expressing the reservations on the formation of CDAI, the SPIC has reportedly called for strengthening of the present system. It also noted that the proposed legislation has no clause for appeal by the companies on the test results in the government labs, which many a time returned wrong results due to many reasons including lack of sufficient infrastructure and efficient personnel.
It also asked for making the DCGI activities more transparent by posting the policies, approvals, names of FDCs and other matters on its website to avoid ambiguities.
The SPIC is learnt to have presented in detail the plight of the SSI sector and the issue of spurious drugs before the panel. It also wanted the regulatory authorities in the country to treat the new drugs listed by the US FDA as new drugs when they were first introduced in India. It urged the panel to recommend laws to equip the Centre to direct the States on the narcotic laws which is now a subject of the State.
Some organizations like IDMA and CIPI had already sent their detailed suggestions to the panel on the formation of the CDAI. The sitting hence had only a few parties turning up for the deposition.
The IMA also stuck to its earlier stand to oppose making the registration of all clinics mandatory under the proposed Clinical Establishments (registration and regulation) Bill 2007, it is learnt.
The panel, which also held sittings in the South early this month, would now tour Indore, Ahmedabad, Mumbai and Goa from February 12 to 19, before preparing the recommendations on the Drugs and Cosmetics (amendment) Bill, 2007.