New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has rejected the applications for retail price fixation of new drugs by certain companies, with a provision to file fresh application once the manufacturing company for these drugs, Synokem Pharmaceuticals, is allowed to start production of the formulations in its facility.
The decision was taken in a meeting held on May 10, according to the drug price regulator. Earlier, the Authority deferred fixing retail price of 11 drug formulations manufactured by Synokem Pharmaceuticals for various marketing companies for want of information from the drug regulator on whether the license of the manufacturing firm has been suspended or cancelled. The Authority sought clarification from the office of the Drugs Controller General (India) and State Licensing Authority (SLA) of Uttarakhand in this regard.
The SLA through a letter dated March 18, 2024 informed NPPA that the drug manufacturing license of Synokem Pharmaceuticals is valid as on date, however, an order of stop production was issued on February 23, 2024 for tablets, capsules and oral liquid section of general category of the firm, in view of violation of Good Manufacturing Practices and Good Laboratory Practices norms as observed during joint inspection on February 16, 2024.
The matter was deliberated in the Authority meeting and based on the regulator’s clarification, it was decided that form I applications of the marketing companies may be rejected and the companies may file fresh form I application when Synokem Pharmaceuticals Ltd in its Uttarakhand unit, is allowed to start production of the applied formulations. The Authority has also listed 11 drug formulations for which the application for retail price fixation was filed for.
A company spokesperson in March, told Pharmabiz that, “We would like to clarify that our manufacturing licence of plant No.1, situated at Plot No. 35-36, Sector 6A has neither been suspended nor cancelled by either CDSCO or FDA – Uttarakhand and would further emphasise here that the directions given are limited to halt the production of lines of the General Block of Plant 1 only and all other operations of the Company are not affected because of this notice”.
“We have filed Corrective & Preventive Action Plan to the regulator and are waiting for a slot for reinspection of the facility by the Joint Team of officials from CDSCO & Uttarakhand FDA to verify the corrective steps taken by us and consider revoking the earlier directions,” it added.
The formulations for which the price fixation has been deferred include various formulations containing dapagliflozin, vildagliptin, sitagliptin and teneliglipt, telmisartan and cilnidipine tablets, among others.
The company, launched in 1983, manufactures more than 1000 pharmaceutical formulations and has its manufacturing facility in Haridwar, Uttarakhand, manufacturing tablets, capsules, liquid orals, ointment, hormonal gels, and sachets. The company is also a contract manufacturing firm for several pharmaceutical companies including some of the industry majors and caters to government and public sector undertakings.
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