Even when Maharashtra Food and Drug Administration (FDA) is trying to implement Schedule H1 Rules, city based chemists rue that around 25 per cent of antibiotics, sedatives and pain-killer drugs are overprescribed by doctors and are purchased in bulk for drug addiction and substance abuse.
Chemists say that dispensing these drugs come with an added burden of maintaining detailed records and prescriptions albeit with a low margin. Medicines are not dispensed at times if the patients do not have valid prescriptions as in some cases doctors don't write clear prescriptions and with even longer validity ranging from over a year to six months. Says a city based physician, "Chemists have stopped stocking sedatives and pain-killers which are covered under Schedule H1 as they are most often irrationally consumed."
Besides this, as per new government notifications, the inclusion of drugs in Schedule H has drastically increased whereas those included in Schedule X have reduced due to some omissions. FDA has also recently recommended the Drugs Controller General of India (DCGI) for inclusion of Codeine, other narcotic drugs and psychotropic substances in Schedule X of the Drugs and Cosmetics Act, 1940. Codeine, other narcotic drugs and psychotropic substances are currently listed under narcotics and psychotropic substances act 1985.
Prescribed mostly for insomnia and anxiety, diazepam containing drugs are extremely cheap and thus chemists don't profit much from them. With the FDA's stringent rules pertaining to schedule H1 drugs, some chemists prefer to keep minimal stocks or no stocks at all. The shortage is artificial, since the drugs are otherwise available with pharma companies.
These low cost drugs fall under the price range of Rs.13.86 for a strip of 10 tablets to the most expensive one costing Rs.40 for a strip of 10 tablets. Pharma companies like Cipla, Ranbaxy, Sun Pharma, Sanofi Aventis etc are some of the companies manufacturing these drugs.
Schedule X comprises of 15 drugs currently as compared to 17 earlier. meprobamate, methylphenidate and amphetamine are some of the drugs which can be misused. Schedule H of the drug and cosmetics act contains a list of 536 drugs which are required to be dispensed on the prescriptions of a registered medical practitioner. In order to have separate regulation to check unauthorised sale of antibiotics, a separate schedule as Schedule H1 has also been introduced under the Drugs and Cosmetics Rules to regulate sale of 46 drugs exclusively.
Drugs covered under narcotic drugs in Narcotic Drug and Psychotropic Substances Act, 1985 are also included in Schedule H of the Drugs and Cosmetics Act like alprazolam, chlordiazepoxide and clobazam which are habit forming drugs.
The 46 drugs under Schedule H1 are sold under more than 3,300 brand names and are available in over 20,000 different combinations. According to experts, "Taking the present scenario into consideration, it has been observed that there is a rapid rise in the research and development activities resulting in the emergence of more new drugs and formulations. This has resulted in categorising these drugs in various schedules of Drugs and Cosmetics Act 1940 and the Rules thereunder."