Drugmakers will be prosecuted for submitting false and misleading information, and DCGI will debar these applicants

New Delhi: The Drugs Controller General of India (DCGI) plans to take action against drug manufacturers who provide misleading and false information to the licensing authority.

At present, there is no provision in the Drug Rules, 1945 to address the issue of providing wrong information for obtaining regulatory approvals.

Under this plan, the applicant can be debarred for misleading the licensing authority, in addition to suspension and cancellation of the product.

The issue was discussed at the Drug Technical Advisory Board (DTAB), the country’s highest technical advisory body on drugs, at a meeting held last month.

“The Board was informed that at present, there is no provision in the Drug Rules, 1945 to address the issue of submission of falsified/fabricated, misleading, etc. data/documents. for obtaining regulatory approvals. Accordingly, it was proposed that provisions may be incorporated in the Drug Rules, 1945 to take action against applicants who submit misleading, false or fabricated documents/data to the licensing authority,” a stated the minutes of the DTAB meeting seen by Mint.

Authorization suspended

In a recent example, the top pharmaceutical regulator last month suspended permission for a pharmaceutical company to manufacture eye drops, citing the company’s unapproved claim.

“If applicants submit false data, for example, name of organization or subjects, or complaints, the regulator makes relevant arrangements to take action against such pharmaceutical companies. Most of these occur within the state licensing authority, and upon further verification, in some cases it was falsified data. The regulator once faced multiple challenges in the absence of provisions in the Drug Rule, 1945,” said an official familiar with the matter.

The Drugs and Cosmetics Act, 1940 and Rules, 1945 ensure the safety, rights and welfare of patients by regulating drugs and cosmetics.

The official added that however, the regulator used to take action as per the provisions mentioned in the Indian Penal Code and file an FIR if necessary. “But inclusion of such provisions in the Drugs Rules, 1945 will make the work of the drug regulator easier and faster,” the official added.

In the present Drugs Rule, 1945, suspension and cancellation of registration certificate or license takes place if the manufacturer fails to comply with any of the conditions of the registration certificate/license , the licensing authority may issue a show cause notice to the applicant or suspend the license or registration certificate.

Questions addressed to the Health Ministry spokesperson remained unanswered as of press time.