Telma H from Glenmark and Ursocol 300 from Sun Pharma are among the 16 drugs classified as false

New Delhi: The Drugs Controller General of India (DCGI) has declared as many as 16 commonly used medicines as counterfeit after they failed the regulator's quality and safety tests.

These include Telma H from Glenmark Pharmaceuticals, which is prescribed by doctors to control blood pressure, and Ursocol 300 from Sun Pharmaceutical to treat gallstones, a drug alert from the DCGI issued by mintsaid.

Other commonly prescribed drugs that have failed the tests of India's top drug regulator include Pulmosil injection for treating pulmonary arterial hypertension and Pantocid for stomach disorders.

These tests come in the backdrop of a number of cases where Indian drugs have failed quality checks abroad. Following this, the Central Drugs Standard Control Organisation (CDSCO) and State Drug Controllers (SDCs) have conducted risk-based inspections at more than 400 establishments in the last one year. As a result, the state regulatory authorities have taken over 300 actions under the provisions of the Drugs Ordinance, 1945, including issuing of notices of hearing, stop production orders, suspensions, cancellation of licences/product licences, etc.

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

“Pulmosil, a drug used to treat pulmonary arterial hypertension, Pantocid used to treat gastroesophageal reflux disease (GERD) and Ursocol 300 mg used to treat gallstones, manufactured by Sun Pharmaceuticals Ltd, have been declared 'false'. The widely used drug Telma H – manufactured by Glenmark Pharmaceuticals Ltd – is used to treat hypertension. The drug has been declared false by the regulator,” the DCGI's drug alert said.

Sun Pharmaceutical Ltd and Glenmark Pharmaceuticals have stated in a response to the drug regulator that the offending batch of the product was not manufactured by them and that it is a counterfeit drug. “The product is alleged to be counterfeit, however this is still under investigation,” they said.

However, spokespeople for both companies declined to comment. mint Query.

Inquiries addressed to the spokesperson of the Ministry of Health remained unanswered at the time of going to press.

Quality control

These substandard and unsafe medicines have been reported by the East Zone Drug Inspectorate, CDSCO, who is tasked with collecting samples to ensure that genuine products are available in the market.

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

Earlier in February, the top drug regulator directed states/union territories to strictly monitor and control the quality of drugs available in the market by conducting random checks. The initiative will help in creating a monthly database of fake and undetectable drugs and keep a check on the manufacturers.

Another important drug, Defcort 6 tablets, has been declared unsafe by the Delhi Drug Regulatory Authority. The drug is used to treat Duchenne muscular dystrophy (DMD), a rare disease.