Schedule H1: 46 drugs under strict prescription norm


Considering drug resistance as a serious health hazard the government of India has brought 46 drugs and their formulations under a new category called 'Schedule H1'. From March 1, all medicines under this schedule will be dispensed by a pharmacist only on prescription of a registered medical practitioner as defined under Drugs and Cosmetics Act. The retailer is expected to maintain a separate record of sale of these medicines in a separate register for at least two years.

These drugs mainly include potent antibiotics (like anti-tuberculosis drugs), habit forming painkillers like Tramadol and anti-anxiety drugs that induce sleep. The ministry of health and family welfare had issued a notification in this regard on August 30 last year by amending the Drugs and Cosmetics Act 1940. None of these drugs can now be sold over the counter (OTC).


Food and Drugs Administration (FDA) joint commissioner (drugs) A V Giri told TOI the Central Drugs Standard Control Organization (CDSCO) has issued an order that the notification will be implemented across India from March 1, 2014. CDSCO would be the enforcing agency. Violation can result in cancellation or suspension of licence and even prosecution. The state drug inspectors or FDA inspectors are authorized to conduct surprise inspection at any retail medicine shop and check the register.

The packaging of Schedule H1 drugs and their formulations shall be labelled with symbol Rx in red and conspicuously displayed on the left top corner of the label. They shall also carry a warning with a red border. The chemist of pharmacist will retain a copy of the prescription. Separate register must have the columns on patient's name and address, doctor's name and address, invoice number date drug and quantity supplied.


Harish Ganeshani, a member of the Maharashtra State Pharmacy Council from city, welcomed the new rule and has called upon all pharmacists to adhere to it. He added the cell numbers of both patients and doctors should also be maintained by the retailer who should always be a qualified pharmacist.

"State government, however, needs to clarify whether or not the retailer should honour prescriptions of these medicines by BAMS doctors and homeopaths. If it does not allow their prescriptions, it will be really good step for us," said Ganeshani. He also added doctors should prescribe anti-anxiety drugs cautiously and only in small quantities. He said if a patient brought a prescription for one month but such a quantity may be misused by patient. "Who will be responsible if the patient ate them all together and died," he asked.

Dilip Jane, a pharmacist and owner of Dattatray Medical Shop in Ramdaspeth, warned against misuse of prescriptions by patients. "We have seen patients bringing prescriptions on forged letterheads without any serial number. Hence doctors prescriptions should have a serial number," he said. Pharmacist should while dispensing medicine put a stamp and mention number of days for which medicine was given.

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3/2/2014 11:29:06 AM