NEW DELHI, 1 FEB, 2013: Some 40 drugs will soon be notified under a new schedule, H1, of Drugs and Cosmetics Act to make it mandatory for chemists to maintain a register of their sales and retain a copy of the prescription. This will be in addition to the schedule H drugs which, too, can’t be sold without prescription.
Besides, packs of H1 drugs will carry a prominent warning in red stating that it is dangerous to take these drugs without doctor’s prescription.
The decision, which Central Drugs and Standards Control Organisation hopes will arrest the rising incidence of resistance to antibiotics in the country, was taken at the 62nd meeting of Drug Technical Advisory Board Wednesday. The final list of drugs, which will largely comprise third and fourth generation antibiotics like imipenem, meropenem, cefaclor, tigecycline and some pain-killers like tramadol, is under preparation. Once it is finalised, the Health Ministry is expected to issue a notification and the Drug Controller General of India will send instructions to states for stringent monitoring and surprise inspections of pharmacies to ensure compliance.
Drug resistance in India, especially among tuberculosis patients — reports of a totally drug resistant TB variety from Mumbai had sent the health fraternity into a tizzy last year — has been a matter of international concern. Revelation of “superbug” NDM1 in 2008 that was resistant to a range of antibiotics and claims that it had originated in Indian hospitals had further aggravated these concerns. So a committee was set up under the former DG, Health Services, to find ways to tackle antibiotic resistance.
“A committee had been set up a while back to look into making drug regulations more stringent in the light of increasing incidence of drug resistance. They had recommended that 86 drugs should be included in a new schedule, but that list had been exhaustive and even first and second generation antibiotics like penicillin, gentamicin, amikacin and norfloxacin had been included. That did not ring prudent to the board so a decision was taken to bring third and fourth generation antibiotics into new schedule H1,” said Dr Jagdish Prasad, DG, Health Services, who chaired the DTAB meeting.
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