The Central government is getting ready to make product-specific labeling requirements mandatory for new drugs even after the end of four years from the date of approval by the Drug Controller General of India (DCGI) to prevent unapproved products and prescription medicines entering the market, sometimes as over-the-counter medications. The Drugs Technical Advisory Board (DTAB), the country’s highest drug advisory body on technical matters, has accepted the proposal to empower the DCGI to initiate action in this regard.

At present, the DCGI grants permission or approval for manufacture of new drug formulations in Form-46 under the provisions of Drugs and Cosmetics Rules 1945 subject to certain conditions such as its classification as a Scheduled Drug or any other specific requirement mentioned as condition of  permission. However, after four years of approval of any new drug, the state licensing authorities take charge and grant all-clear to manufacture it without putting any stringent conditions in respect of its sale and the drug may be available in the market as non-prescription drug.

As per Rule l22E of the Drugs and Cosmetics Rules, a new drug shall continue to be considered a new drug for a period of four years from the date of its first approval.

At its meeting on May 16, the DTAB recommended to empower the DCGI for issuing drugs-specific labeling requirements after completion of new drug status at the end of four years from the date of approval and forward the information to the state drug controllers along with the specific labelling requirements. The state authorities have to incorporate these labeling norms as a condition for offering licence so as to ensure that the drug is not sold as non-schedule drug till it is included in the Schedule H, H1 or X.

It may be noted that the Central Drugs Standard Control Organisation (CDSCO) officials had recently conducted surprise raids and issued notices to several pharmaceutical manufacturing firms located in Uttarakhand and Sikkim which were producing medicines not cleared by the CDSCO. According to industry sources, state drug control authorities are granting licences without approval from the central authority or adequate safety trials. The products seized during inspections in Haridwar included anti-fungal medicines, creams and diabetes drugs.