Amendment to Drugs & Cosmetics Act Deferred

IMPORTANT NEWS

The much talked about amendment in the Drugs and Cosmetics Act, that was to regulate the indiscriminate use of antibiotics, has been deferred by Union Health Minister Ghulam Nabi Azad. Health Ministry sources confirmed that at a meeting on Wednesday, the minister had decided on a review of the policy for the time-being.

The amendment would have introduced a new Schedule HX to the Act and would have made prescription-based sales compulsory for 74 listed drugs. Azad has reportedly said the policy that had been drafted by the office of the Drug Controller General of India (DCGI) — the drug regulatory authority under the ministry — was "not practical" considering the dearth of qualified doctors in rural areas.

"The amendment has not been dropped, it is just deferred for the time being," a ministry spokesperson confirmed. According to a senior official, "In the absence of sufficient number of doctors, making prescription-based sales compulsory for common drugs would affect patients adversely."

The schedule would also be compulsory for doctors to issue double prescriptions, one copy of which had to be retained by chemists for at least two years, while the other would be part of DCGI records, to check the over-the-counter sales of antibiotics.

These prescriptions would provide a suitable way to maintain a count of antibiotic use, which has been totally absent in the country. To regulate the availability of antibiotics, the schedule also lists 16 other drugs, which would have to be sold directly by the manufacturers to tertiary care hospitals.

Chemists had raised objections citing the lack of doctors and tertiary care centres in rural areas.