The Union health ministry has constituted a sub-committee to prepare guidelines and suggest amendment, if any, required under the Drugs and Cosmetics (D&C) Rules, 1945 for regulating the transportation of drugs in the country.

Director General, Drugs, Andhra Pradesh; Commissioner, FDCA, Gujarat; Drugs Controller, Himachal Pradesh; Drugs Controller, Odisha and Drugs Controller, Goa are the members of the committee which has been asked to submit its report within three months. K Bangarurajan, DDC(I), CDSCO, HQ, New Delhi is the convener of the committee.

Drafting a guidelines for regulating the transportation of drugs in the country is a significant step as at present there are no rules or guidelines in D&C Rules 1945 to be followed by transport agencies who are engaged in transport of drugs. Drugs remain stocked for longer time in transport agencies are not being stored properly thereby losing their potency. Many a time the spurious drugs, physician samples, drugs without proper documents which are seized from the transport agencies and the investigation could not be proceeded further because of lack of details of the persons who booked and dealt with such drugs.

Besides, there is no rule or section in the D&C Act 1940 and Rules 1945 to monitor the activities of transport agencies who deal with the transport of drugs.

The issue was discussed at the Drugs Consultative Committee (DCC) meeting held on November 12 and 13, 2013 which was presided over by DCGI Dr GN Singh, who is also the DCC chairman.

At the meeting, the DCC members agreed that guidelines are needed to regulate the transportation of the drugs as not only the drugs are transported like ordinary commodities to the different regions having diverse climatic conditions, but also stored improperly by the transport agencies. Even proper documentation is not maintained by the transporting agencies.

Members further felt that the D&C Rules 1945 is to be amended to incorporate a special rule to register or license the transport agencies by prescribing certain conditions of license to store the drugs properly during transport/stocking and to register the details of the persons who are booking the drugs for transport or persons who are dealing with the drugs through transport.