Government notifies Schedule H1 drugs

As many as 46 drugs have been placed under restricted category

September 27, 2013 10:24 pm | Updated June 02, 2016 03:36 pm IST - NEW DELHI:

With the Union Health and Family Welfare Ministry notifying amendments to the Drugs and Cosmetics Act 1940, antibiotics and anti-Tuberculosis drugs will not be sold over the counter from March 1, 2014.

The government had included a new provision, Schedule H1 to the Drugs and Cosmetics Act to check the indiscriminate use of antibiotics, anti-TB and some other drugs in the country. As many as 46 drugs have been placed under this restricted category which mainly comprises third and fourth generation antibiotics, anti-TB and some other drugs.

The packaging of these drugs will have mandatory warning printed on them in a box with a red border on the label and will be sold by chemists on production of a prescription. The chemist will retain a copy of the prescription and maintain a separate register for these 46 drugs where the name of the patient and the details of the doctor who prescribed the drugs will be noted. This register will have to be kept for three years before being destroyed.

The Central Drugs Standard Control Organisation (CDSCO) has the responsibility to enforce the order. Violation of this provision can result in prosecution. State Drug Inspectors can conduct surprise inspections at the pharmacies and chemist shops to check the registers and sale of these 46 drugs under Schedule H1.

Restricted sale of antibiotics was one of the main recommendations of the Chennai Declaration to check drug resistance which is emerging as a serious health issue in the country. Resistance to antibiotics and an increase in drug resistant TB cases are cited as a result of improper prescription and consumption of antibiotics which are easily available.

The Chennai Declaration, adopted last year, recommends urgent measure to formulate an effective national policy to control the rising trend of antimicrobial resistance, including a ban on over-the-counter sale of antibiotics, and changes in the medical education curriculum to include training on antibiotic usage and infection control.

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