Telma H from Glenmark and Ursocol 300 from Sun Pharma among 16 drugs classified as spurious

New Delhi: The Drug Controller General of India (DCGI) has declared 16 commonly used drugs spurious after they failed the regulator’s quality and safety tests.

These include Glenmark Pharmaceuticals’ Telma H, prescribed by doctors to control blood pressure, and Sun Pharmaceutical’s Ursocol 300, used for the treatment of gallstones, a drug alert issued by DCGI and viewed by Mintsaying.

Other widely prescribed drugs that have failed tests by India’s top drug regulator include Pulmosil injection, used to treat pulmonary arterial hypertension, and Pantocid for gastric problems.

These tests come in the backdrop of a few cases of Indian drugs failing quality checks abroad, following which the Central Drugs Standard Control Organisation (CDSCO) along with State Drug Controllers (SDCs) have conducted risk-based inspections of over 400 establishments in the last one year. As a result, over 300 actions such as issuance of show-cause notices, stop production orders, suspension, cancellation of licences/product licences etc. have been taken by the State licensing authorities under the provisions of the Drugs Rules, 1945.

Paziva –40, Pantomed –40, Cefixime Oral Suspension IP, Moxymed CV, Furosemide Injection IP 20 mg, Tab Nodosis, Pantoprazole Injection BP 40 mg —were listed as ‘non-standard quality (NSQ)’ in the regulator’s database for the month of August.

“Pulmosil, an indication used to treat pulmonary arterial hypertension, Pantocid used against gastroesophageal reflux disease (GERD), Ursocol 300 mg used for the treatment of gallstones manufactured by Sun Pharmaceuticals Ltd have been detected as ‘spurious’. The popularly used drug Telma H manufactured by Glenmark Pharmaceuticals Ltd is used to control high blood pressure. The regulator has declared the drug spurious,” the drug alert issued by the DCGI said.

Sun PharmacyIn a response to the drug regulator, Ceutical Ltd and Glenmark Pharmaceuticals have claimed that the contested batch of the product was not manufactured by them and that it is a spurious drug. “The product is presumed to be spurious but is subject to the results of the investigation,” they said.

Spokespeople for both companies, however, declined to comment. Mint consultation.

Questions sent to the spokesperson of the Ministry of Health remained unanswered by the time this edition went to press.

Quality control

These poor quality and unsafe medicines have been reported by the drug inspector of the Eastern Zone. CDSCOwhich is mandated to select samples to ensure that the genuine product is available in the market.

During 2022-23, at least 3,053 substandard and 424 fake or adulterated medicines were found, Union Minister of State for Health and Family Welfare Anupriya Patel said in Parliament in July.

Earlier in February, the top drug regulator had directed states and Union Territories to maintain strict vigil on the quality of medicines available in the market by conducting random sampling of drugs. The initiative helps create a monthly database of fake and substandard medicines and keep a check on manufacturers.

The drug regulator in Delhi has ruled another major drug, Defcort 6 Tablets, unsafe. It is indicated for use in treating Duchenne muscular dystrophy (DMD), a rare disease.