The Drug Technical Advisory Board (DTAB) has recommended the re-examining of the definition of spurious drugs and set up a sub-committee to finalise the guidelines regarding the advertisements of emergency contraceptive pills which will continue as over-the-counter drugs still.

The technical body on drugs, which met here on Monday, with the Director General of Health Services in chair, decided not to disturb the status of the emergency contraceptive pills. However, the board set up the sub-panel with two gynaecologists, a member of Federation of Obstetric Societies of India (FOGSI), one person from the Ministry of Information & Broadcasting and a pharmacologist as members. The committee will finalize the guidelines regarding the advertising of emergency contraceptive pills with special focus on the safe use of such drugs, according to an official release.

With regard to the drug Letrozole a sub-committee with head of Gynaecology PGI Chandigarh will be formed to review marketing of the drug. The Board meeting also decided to amend Drugs & Cosmetics rules to make provisions for registration of organization/individuals for conducting clinical trials.

The Board also considered the issue of re-examining the definition of spurious drugs. It was decided that the definitions should be re-examined in the light of fact that cause of Indian exports of drugs and availability of affordable drugs in the country is not adversely affected. Mechanism for re-examination will soon be in place.

The Board also considered re-examination of continued marketing of certain drugs which have been reported to be prohibited or restricted in certain countries. A sub-committee with a representative each of Indian Medical Association, ICMR, a clinician, a physician, two pharmacologists, representative of Drug Controller and a veterinary specialist will decide on the issue, the release said.

These drugs are phenylpropanolamine or PPA (Vicks Action-500, Solvin), painkiller nimesulide (Nice and Nimulid), letrozole (Letroz), gastrointestinal tegaserod (Ibsinorm, Tegod, Tegibs), anti-bacterial gatifloxacin (Gaity) and human placenta extract (Placentrex lotion and gel sold by Albert David). The committee will take feedback from the industry on the performance of these drugs before making a final decision.