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29 Jan 2015

Significance and introduction of Schedule H1 Drugs under Drug and Cosmetics Act

Background of the introduction: 

Followed by the recent notification by Government of India (GOI) to omit 40 drugs from Schedule H, the drugs are included in the new Schedule H1. The Drug Controller General of India (DCGI) issued a notification based on the recommendations tabled by Drug Technical Advisory Board of India (DTAB), a technical advisory division of Central Drugs Standard Control Organization (CDSCO).

Significance of Schedule H1 drugs:

In accordance with the new notification and inclusion of drugs in the new Schedule H1, the drugs will carry a Boxed Label Warning that should not be sold without a prescription issued by Registered Medical Practitioner and self-medication of the drug preparation can be dangerous. The new rule mandates the chemists and druggists to maintain sales register and to retain the physician’s prescription copy as a proof of drug sales. Upon finalization, the Ministry of Health will issue a notification to DGCI to direct all the chemists and druggists to comply with the Ministry’s regulation.

Which drugs are included in schedule H1?

The list of drugs that are included in the new Schedule H1 are Antibiotics, Buprenorphine, Cefadroxil, Cefazolin, Cefdinir, Ceftazidime, Ceftizoxime, Cefuroxime, Chlordiazepoxide, Ciprofloxacin, Clarithromycin, Clindamycin, Codeine, Detropropoxyphene, Gatifloxacin, Diazepam, Diphenoxylate and its salts, Ethambutol, Aztreonam, Isepamicin, Levofloxacin, Linezolid, Meropenam, Midazolam, Moxifloxacin, Alprazolam, Nalidixic acid, Nitrazepam, Norfloxacin, Ofloxacin, Pentozocine, Pyrazinamide, Amikacin, Sparfloxacin, Tramadol Hydrochloride, Minocycline, Tobramycin, Cotrimoxazole and Zolpidem.

The aim of the GOI’s initiative is to curb the increasing incidence of antibiotic resistance including the emergence of MRSA, MDR-TB, XDR-TB, irrational drug use (sedatives and hypnotics) and to check indiscriminate prescription of antibiotics.

Key Points of Schedule H1 regulation  – 

  • Major objective of Schedule H1 drug is to control the un-restricted use of antibiotics.
  • This specified list of drugs should be sold by chemists only after retaining a copy of the prescription by them.
  • The packs of these drugs should have a warning in a box with a red border on the label.
  • Some of the third and fourth generation antibiotics to be included in the list are imipenem, meropenem, cefaclor, tigecycline and some pain-killers like tramadol.
  • After the notification, the CDSCO is expected to take steps to enforce the order by conducting surprise inspections in the pharmacies.

Resistance to drugs, mainly to antibiotics, has emerged as one of the world’s most pressing public health problems of today with some of the infectious diseases becoming untreatable with the existing drugs. The main reason for this trend is the tendency of the physicians to prescribe this class of drugs as an easy option even for a minor infection. And there has been no control over the prescriptions by doctors as it is considered to be a technical work and the authorities left that decision entirely to the medical profession. Ideally, antibiotics need to be prescribed in optimal doses, regimens and should be stopped when the infection is treated. It is important that the use of last line antibiotics should be restricted to serious infections and only when simpler drugs do not work. Whenever used for prophylaxis, antibiotics should be used for short courses and at appropriate times. As in case of any rules, enforcement of the new provision in the D&C Act is going to be tough job for the drug regulators. Inspection of 6 lakh pharmacies across the country and monitoring prescriptions of doctors countrywide may turn out to be a massive task for the government and the existing machinery is not equipped for that. Apart from the private hospitals and clinics, large number of government hospitals and primary health centres are probably a much bigger frontier where antibiotic prescriptions are currently generated on a big scale. Office of the DCGI and the state drug control administrations have to seriously think about how to check this practice at these levels. Formation of antibiotics committees with adequate powers in district and taluk level hospitals and PHCs could be one effective way to implement Schedule H1.

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