CDSCO asks drugmakers to market Tolperisone, Paracetamol FDC solely for revised indication

New Delhi: The Central Drugs Standard Control Organization (CDSCO) has directed all State and Union Territory (UT) drug controllers to instruct all manufacturers of Fixed Dose Combination (FDC) of Tolperisone HCL 150mg and Paracetamol IP 500mg to market only for "symptomatic treatment of post stroke spasticity associated with pain in adults."

In addition, the manufacturers of the said FDC have been directed to submit the Phase IV clinical trial protocol for the revised indication as soon as possible for further review.

Tolperisone is an oral, centrally acting muscle relaxant. On the other hand, paracetamol, also known as acetaminophen, is a medication used to treat fever and mild to moderate pain.

Through a recent notification, the Drugs Controller General of India has informed that the FDC of Tolperisone HCI 150mg plus Paracetamol IP 500mg tablet was initially approved on 21.10.2010. 

However, in line with the 59th report of the Parliamentary Standing Committee (PSC) dated 08.05.2012, it was decided that the FDC of Tolperisone HCI 150mg + Paracetamol IP 500mg tablet would be referred to the New Drug Advisory Committee (NDAC)/Subject Expert Committee (SEC) for examination and review related to its continued marketing and updating of the product monograph in light of recent knowledge and regulatory changes overseas.

Accordingly, the matter was discussed at the 26th SEC meeting for Analgesics & Rheumatology meeting held on 08.09.2016, wherein the Committee noted that the FDC of Tolperisone HCI 150mg + Paracetamol IP 500mg tablet was approved by this office on 21.10.2020 for the treatment of patients with acute painful musculoskeletal conditions.

In continuation, the committee reviewed the FDC in light of the recommendation of the Parliamentary Standing Committee (PSC) regarding the said FDC's continued manufacturing and updating of product monographs in light of recent knowledge and regulatory changes overseas.

After extensive deliberation, the committee concluded that the FDC should only be marketed for symptomatic treatment of post-stroke spasticity accompanied with pain in adults. It was also suggested that the company conduct a Phase IV trial on the revised indication. As a result, the protocol should be sent to be reviewed further. The company should make the required modifications to its package insert.

In accordance with the recommendation, the notice stated that the initial applicant was asked to conduct a phase IV clinical trial. However, the firm surrendered the original product permission on 10.10.2017.

Accordingly, the notice added, "As the FDC of Tolperisone HCI 150mg + Paracetamol IP 500mg tablet is no more a new drug, you might have issued the product license for the same FDC to other manufacturers."

In view of the above facts and circumstances, the Directorate General of Health Services has requested all State/UT Drug Controllers to direct all the manufacturers of said FDC under their respective jurisdiction to market the subject FDC only for "symptomatic treatment of post stroke spasticity associated with pain in adults".

In addition, the notice stated that the manufacturers of this FDC should also be directed to submit the Phase IV clinical trial protocol for the revised indication to this office at the earliest for further review.

To view the official notice, click the link below: