Drugmakers to face action for submitting wrong and misleading info, DCGI to debar such applicants

New Delhi: The Drugs Controller General of India (DCGI) plans to take action against drug makers that give misleading and fake information to the licensing authority.

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

As part of the plan, the applicant may be debarred for misleading the licensing authority, in addition to their suspension and cancellation of the product.

The matter was discussed in the Drugs Technical Advisory Board (DTAB), the country’s top technical advisory body on drugs, in a meeting held last month.

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“The Board was apprised that at present there is no provision under the Drugs Rules, 1945 to address this issue of submitting forged/fabricated, misleading data/document, etc for obtaining the regulatory approvals. Accordingly, it was proposed that provisions may be incorporated under the Drugs Rules, 1945 for taking action against applicants for submitting misleading, or fake or fabricated documents/data to the licensing authority,” stated DTAB minutes of meeting seen by Mint.

Permission suspended

In a recent example the apex drug regulator last month suspended the permission granted to pharmaceutical firm to manufacture eye drops, citing the company’s unapproved claim.

“If in case, the applicants submit fake data- for example- name of the organization or subjects, or claims, the regulator is making relevants provisions to take actions against such drug firms. Most of these happen in the state licensing authority and upon verification later, in some cases, it used to be forged data. The regulator used to face multiple challenges in the absence of provisions in the Drug Rule, 1945,” said an official familiar with the matter.

The Drugs & Cosmetics Act,1940 and rules 1945 ensures the safety, rights and wellbeing of the patients by regulating the drugs and cosmetics.

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

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

Queries sent to the health ministry spokesperson remained unanswered till press time. 

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