The Federation of Indian Pharmacist Organisations (FIPO), in an RTI application, has demanded to DCGI Dr G N Singh to divulge the report of actions taken by state licencing authorities (SLAs) on the circular issued by his office on January 5 this year with regard to cancellation of licences (product permission) for manufacturing and marketing the drug, Mesalamine USP 800 mg tablet.

The DCGI also wanted the SLAs to direct the manufacturing firms to recall the product from the market that they have already manufactured and marketed. The circular signed by Dr G N Singh asks state regulators to intimate him the actions already taken in this regard.

According to DCGI, several companies are manufacturing and marketing Mesalamine USP 800 mg tablet which has not yet been approved by his office. Since the formulation falls under the category of ‘New Drug’ as per rule 122B of the Drugs and Cosmetics Rules, 1945, manufacturing license has to be issued by the DCGI office.

“This formulation falls under the category of ‘New Drug’ under Rule 122B of the Drugs and Cosmetics Rules, 1945. Therefore, for its manufacture all the applicants should submit application in Form 44 of the D&C Rules to this Directorate with requisite fee along with necessary documents for grant of approval. Grant of licence without permission from the licencing authority (DCGI) under Rule 21 (b) is in contravention to Drugs and Cosmetics Act, and Rules made under there, as well as this causes loss of revenue to the central government,” the circular points out.

Since the circular of Dr G N Singh wants the state licencing authorities to cancel the licence (product permission) and direct the firms to recall Mesalamine USP 800 mg tablet from the market, Dr R S Thakur, president of FIPO, has sent 11 questions to the DCGI asking explanations about the progress of actions taken by each SLA. Dr Thakur says that a period of 18 weeks have already passed after the circular was issued, hence it is imperative to know the impact.

He wanted the national regulator to furnish state wise list of firms which were licenced to manufacture Mesalamine USP 800 mg tablet, and each company’s monthly details of the quantum of manufacture and marketing of the product. Details regarding how many state authorities have cancelled the licences and how many companies have recalled the product from the market have been solicited.

The RTI letter further needs explanation in respect of the fate of the recalled product and what was the turnover of the drug. It also wants details about the financial loss caused to the central government due to licence given by state authorities and what action DCGI is going to take against the erred SLAs.

Three years ago, there was allegation that the drug licencing authority of Pondicherry had given permission to some companies for manufacture of some FDC products which came under new drug category. Following it, the DCGI office conducted enquiry and the government of the Union territory took severe action against the SLA.