The Union health ministry has allowed the chemists to sell antibiotics listed under the Schedule H1, but manufactured before February 28, without the new labelling requirements even as the notification regarding the antibiotics has come into effect from March 1.
However, the chemists have been asked to follow other instructions for the sale of these antibiotics with regard to prescription and maintenance of sale records as per the amended rule under the Schedule H1, according to the official sources.
The relaxation was given following the representations by the trade bodies citing difficulties in relabelling of the products manufactured earlier. The Government had notified the amendment to include Schedule H1 under the Drugs and Cosmetics Rules 1945 on August 30, 2013, containing certain antibiotics, anti-TB drugs and habit forming drugs. The notification has come into effect from March 1, 2014, after the stipulated time of six months.
“The representations were received from the drug manufacturers associations as well as individual manufacturers that the chemists may not be able to sell the drugs covered under the Schedule HI which are not labelled as per the provisions of the amended rules even though these drugs at the time of their manufacture were labelled in accordance with the rules applicable to them,” said a notice from the Drug Controller General of India (DCGI).
“The representations have been considered by the Ministry of Health and Family Welfare and it has been decided that the drugs included in the Schedule H1 manufactured upto February 28, 2014 without the labelling requirements specified in the notification but labelled as per provisions applicable for them at the time of their manufacture, may continue to be sold beyond March 1, 2014. The chemist, while selling the drugs included in Schedule H1 would however be required to comply with the requirements for the sale of drugs covered under the said notification in respect of requirements of sale of these drugs against the prescription of an RMP and maintenance of sales records as specified therein,” the notice said.
After dilly-dallying on the issue of antibiotics policy for long, the Government had amended the Drugs and Cosmetics Rules to insert Schedule H1 category to regulate the use of antibiotics in the country, but placing 46 antibiotics under category instead of original proposal to include 91 drugs.
The government made it compulsory for these listed antibiotics to carry warning also. “If it contains a drug substance specified in Schedule H1, the drug formulation shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label,” according to the official notification by the health ministry.
Antibiotics falling under third and fourth generation and several habit forming drugs are in the list. Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefixime, Cefoperozone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codein, Cycloserine, Diazepam, Diphenoxylate, Doripenem, Ertapenem, Ethambutol Hydrochloride, Ethionamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Rifabutin, Rifampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem are the drugs included in the list.