Significance of Schedule H1 Drugs
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).
Schedule H1 drugs must 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.
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  -Â
- 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.
Obligations of Chemists while selling Schedule H1 Drugs
To strengthen monitoring, it is mandatory to retain a copy of each prescription for drugs covered under Schedule H1 in a separate record. This record should be maintained for three years and made readily available for inspection. Furthermore, whenever a drug listed under Schedule H1 is supplied, details must be documented in a separate register at the time of supply. This register should include the name and address of the prescriber, the patient’s name, the name of the drug, and the quantity supplied. This record, too, must be maintained for three years and be accessible for inspection.
Frequently Asked Questions regarding Schedule H1 Drugs?
What is Schedule H1?
Schedule H1 is a category under the Drugs and Cosmetics Rules, 1945, that lists specific drugs, particularly antibiotics, anti-TB drugs, and certain psychotropic medications. These drugs require special control and monitoring due to their potential for misuse, leading to issues like antibiotic resistance.
Why was Schedule H1 introduced?
Schedule H1 was introduced to combat the growing problem of antibiotic resistance and prevent the misuse of certain medications. It aims to ensure these drugs are prescribed responsibly and are only available through qualified prescriptions.
What is required to obtain a Schedule H1 drug?
To obtain a Schedule H1 drug, a valid prescription from a registered medical practitioner is required. The pharmacist must keep a copy of the prescription in a separate record for at least three years, and the details of the supply must be logged in a special register.
What drugs fall under Schedule H1?
Schedule H1 drugs primarily include specific antibiotics, anti-TB drugs, and psychotropic substances that require strict regulation. The exact list of drugs covered under Schedule H1 is outlined in the Drugs and Cosmetics Rules.
What information needs to be recorded when dispensing a Schedule H1 drug?
When dispensing a Schedule H1 drug, the pharmacist must document the following details in a separate register:
- Name and address of the prescriber
- Name of the patient
- Name and quantity of the drug supplied
This record must be maintained for three years and be available for inspection.
How long must the prescription and dispensing records be retained?
The prescription and dispensing records for Schedule H1 drugs must be retained for a minimum of three years.
What is the penalty for violating Schedule H1 regulations?
Violations of Schedule H1 regulations, such as dispensing these drugs without a proper prescription or failing to maintain records, can lead to legal penalties, including fines, suspension of pharmacy licenses, and, in severe cases, imprisonment.
Who can inspect Schedule H1 records?
Authorized officials from the Drug Control Department or other designated regulatory bodies can inspect Schedule H1 records to ensure compliance with regulatory requirements.
Are all antibiotics included under Schedule H1?
No, Schedule H1 drugs cannot be sold over-the-counter. They must only be dispensed with a valid prescription from a registered medical practitioner and in compliance with specific documentation requirements.
What role do healthcare professionals play in implementing Schedule H1 regulations?
Healthcare professionals, including doctors and pharmacists, play a critical role by prescribing and dispensing these drugs responsibly, educating patients on the importance of correct antibiotic use, and ensuring all regulatory guidelines are strictly followed to prevent misuse.
Additional Discussion on Schedule H1 Drugs
The resistance to drugs, particularly antibiotics, has become one of today’s most urgent global public health challenges, with certain infectious diseases now proving untreatable by existing medications. This trend can largely be attributed to the common practice among physicians of prescribing antibiotics as an easy solution, even for minor infections. Currently, there is minimal control over these prescriptions, as it is regarded as a technical decision, and the responsibility has largely been left to the discretion of medical professionals.
Ideally, antibiotics should be prescribed in optimal doses and regimens and discontinued once the infection is resolved. The use of last-resort antibiotics must be limited to severe infections and only when less potent drugs prove ineffective. Additionally, when antibiotics are used for preventive measures, it is crucial that they are administered for brief periods and at appropriate times.
However, enforcing the recent changes to the Drugs and Cosmetics (D&C) Act presents a significant challenge for drug regulators. Monitoring six lakh pharmacies across the country and overseeing the prescriptions of doctors on a national scale could become an overwhelming task for the government. The current infrastructure is not equipped for such extensive oversight.
In addition to private hospitals and clinics, a vast number of government hospitals and primary health centers contribute significantly to the volume of antibiotic prescriptions. Thus, the offices of the Drug Controller General of India (DCGI) and state drug control administrations need to consider robust strategies to address this practice at all levels of healthcare.
One potential solution could be establishing antibiotic committees with sufficient authority at district and taluk-level hospitals, as well as in primary health centers. Such committees could play a pivotal role in enforcing Schedule H1 regulations and ensuring antibiotics are prescribed responsibly.
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