21-Apr-2019: Medicine labels in regional language

In order to counter fake, sub-standard and expired drugs, the Union Health Ministry has said Hindi and regional language will be used in the tendering process.

Drug names and expiry date during tendering will be in Hindi/regional language too for — polio drop and Iron tablets — procured for children under the government programmes.

The Drugs Technical Advisory Board (DTAB) recently recommended that government procurement agencies should take necessary steps in the tendering process to include the regional language, along with English, on the label of iron tablets and polio drops in government programmes.

An advisory may be issued by the government. Also a sub-committee may co-opt the representatives from the pharmaceutical manufacturing industry and Indian Pharmaceutical Association for further deliberations on the overall issues related to labelling requirements of drugs.

Since last year, the government has been working on ensuring the most stringent quality control for both the products which directly affect almost all the children born in India.

DTAB, in a meeting held early last year, considered the proposal to amend Rule 96 of the Drugs and Cosmetics Rules, 1945 for labelling of iron tablets and polio drops distributed to the children under government programmes with name and expiry date in Hindi also. The Board then constituted a sub-committee under the chairmanship of Dr. R.N. Tandon, honorary secretary general, IMA, New Delhi to examine and give recommendations to streamline the labelling requirements of drugs so as to provide the requisite information to the consumer.

9-Feb-2019: Medical devices to be treated as drugs

The Centre in a notification said that medical devices — all implantable devices, CT Scan, PET and MRI equipment, defibrillators, dialysis machines and bone marrow separators — will be treated as drugs for human beings with effect from April 1, 2020.

The decision was taken in consultation with the Drugs Technical Advisory Board.

Majority of medical devices are completely unregulated in India. With this move, all implantable devices and some diagnostic equipment will be brought into the regulatory framework which is important from a patient safety perspective.