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Drug control agency drafts rules on third-generation antibiotics

Drug control agency drafts rules on third-generation antibiotics

New Delhi: Even as the health ministry drags its feet over a national antibiotic policy, the Central Drugs Standard Control Organisation has prepared draft notifications that will regulate antibiotic drugs and the treatment of infectious diseases.

The drafts were submitted to the health ministry on Monday.

Also See Superbug Scare (PDF)

A 28 October meeting of the drugs consultative committee (DCC), chaired by the drug controller general of India (DCGI) with state drug regulators as members, took two major decisions.

First, it proposed that third-generation antibiotics, or those given only when no other antibiotic is effective, will be allowed to be prescribed only in tertiary care hospitals.

Secondly, it decided to more strongly regulate antibiotic, anti-tuberculosis and anti-anxiety drugs, some of which can be habit forming.

As part of this decision, DCC sent a draft notification under which a new schedule—to be called HX—will be created in the Drugs and Cosmetics Act for such drugs, The Indian Express newspaper reported on 29 October.

India’s lack of an antibiotic policy came to light in August when the Lancet Infectious Diseases journal published a report that linked a drug-resistant superbug to India. The superbug can cause multiple organ failure and was named New Delhi metallo-beta-lactamase in the report.

Although the health ministry refuted the report, it got into damage control mode, and in September, announced plans to prepare a national antibiotic policy. It appointed a committee to prepare a draft within six weeks. Nine weeks later, the draft is still not ready.

“Different members of the committee are preparing different parts of the draft, so it is taking time," said N.K. Ganguly, a member of the panel and advisor to the ministry. “But it should be out anytime soon."

According to DCGI Surinder Singh, doctors in India are prescribing strong third-generation antibiotics for simple ailments.

“This leads to antibiotic resistance. And since the antibiotic that was meant to be the last resort has already been prescribed as the first line of treatment, there are no other options of treatment left," Singh said. “Hence, to regulate the use of third-generation antibiotics, we will allow them to be prescribed only by doctors in tertiary care hospitals, and also regulate the prescription practice of doctors."

The new proposed schedule HX will be a mix of schedules H and X. Nearly 70 drugs will be covered under it. Schedule H refers to a regulation under which drugs can be sold only on prescription. The more stringent schedule X makes it mandatory that only certified schedule X chemists be allowed to sell the drug, and doctors have to write two prescriptions of the drug, one of which will be kept by the doctor and the other by the chemist for at least two years.

The drugs falling in schedule HX will require that the doctor and the chemist retain the prescriptions for at least one year. Violation could lead to 1-2 years in prison and a fine of 20,000.

For the drafts to be notified, they will have to be approved by the health and law ministries and ratified by the Drug Technical Advisory Board, the highest drug advisory board in India, within six months.


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