The new subcommittee constituted by the Drugs Consultative Committee (DCC) of the Central Drug Standards Control Organisation (CDSCO) would suggest addition of about 15 new drugs to the list under Schedule P of the Drugs & Cosmetics Act.
The Schedule P of the D&C Act, which deals with the standards that required to be enforced for maintaining the recommended shelf life of drugs, has enlisted 80 products at present. The drugs, which are likely to be included in the list, are mainly new generation antibiotics, anti-retroviral drugs and few other drugs approved for manufacturing and marketing in the country post 2000.
The Subcommittee headed by Dr S P Adeshara, commissioner, FDCA- Gujarat comprises of Dr M Venkateshwarlu, deputy drug controller, India- West, Commissioner, FDA Maharashtra, drug controller, Andhra Pradesh and Dr Jogi, director, Central Drug Testing Laboratory, Maharashtra. The committee, which will meet on March 17 in Ahmedabad, would suggest the expansion of drugs list as well as the corresponding storage guidelines to be incorporated in Schedule P to the DCC.
It may be recalled though the CDSCO has prepared amendments to Schedule P of the Drugs and Cosmetics Act to incorporate new storage guidelines for chemists and druggists in the country, the notification in this regard is yet be made.
It is also learnt that the industry is quite apprehensive about the possible infrastructure bottlenecks while implementing the guidelines.
The amendments proposed by the drug authorities suggest a complete air-conditioned facility with special arrangements of cold storage for keeping vaccines and injectables. It also insists on fully computerized operations in the shop. Besides, new laws are being suggested to minimize the possibilities of airborne contaminations in formulations.
The proposed amendments suggest that antibiotics like ampicillin, adramycin amoxycillin and bacitracin have to be stored only in a cool place and carbenicillin sodium injection and carbenicillin sodium powder, have to be kept at a temperature not exceeding 5 degree celsius. It also states that some antibiotics need to be kept in a properly closed container with temperature not exceeding 30 degree celsius. Similarly, vitamins -- vitamin A, B, Injections, Thiamine Mononitrate should be kept in a well-closed container, protected from light and in a cool place.