Glenmark’s Telma H, Sun Pharma’s Ursocol 300 among 16 drugs termed spurious

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

These include Glenmark Pharmaceuticals’ Telma H, prescribed by doctors to manage blood pressure, and Sun Pharmaceutical’s Ursocol 300 used for gallstones treatment, a drug alert issued by DCGI, and seen by Mint, said.

The other heavily-prescribed medicines that have failed India’s apex drug regulator’s tests include Pulmosil injection used for managing pulmonary arterial hypertension, and Pantocid for gastric issues.

These tests come in the backdrop of some instances of Indian medicines failing quality checks abroad, following which Central Drugs Standard Control Organisation (CDSCO) along with state drugs controllers (SDCs) have conducted risk-based inspections of more than 400 premises in the last one year. As a result, over 300 actions like issuance of show-cause notices, stop production order, suspension, cancellation of licences /product licences etc. have been taken by state licensing authorities as per the provisions of the Drugs Rules, 1945.

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Paziva –40, Pantomed –40, Cefixime Oral Suspension IP, Moxymed CV, Frusemide Injection IP 20 mg, Tab Nodosis, Pantoprazole Inj. BP 40 mg ---were listed in 'not of standard quality (NSQ)' by the regulator’s database for the month 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”. Popularly used Telma H drug-- manufactured by Glenmark Pharmaceuticals Ltd is used for managing high blood pressure. The drug has been declared spurious by the regulator,” stated the drug alert issued by DCGI.

Sun Pharmaceutical Ltd and Glenmark Pharmaceuticals, in a reply to the drug regulator, have said that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. “The product is purported to be spurious, however, the same is subjected to outcome of investigation,” they said.

“At the outset, we would like to categorically state that the product mentioned in the list is counterfeit and has not been manufactured or distributed by Glenmark. This has been confirmed by the regulatory authorities,” a Glenmark spokesperson said.

"As a responsible organization, Glenmark has always prioritized patient safety and the quality of our products. To deal with the menace and tackle this issue of counterfeit products, we have implemented advanced security measures to ensure the authenticity of our products. These efforts include the use of unique product identifiers, strengthening our supply chain, and actively monitoring the market to detect and quickly respond to any counterfeit threats.

In light of these issues, we urge all pharmacy outlets to ensure they source Glenmark products exclusively from our authorized stockists. This is crucial for maintaining the integrity and quality of the medications provided to patients.

We are working closely with the regulatory authorities to eliminate the menace of counterfeit products and protect consumers. Glenmark remains fully committed to safeguarding patients and continuously enhancing the measures we take to ensure the integrity of our products,” the spokesperson said.

The spokesperson of Sun Pharma declined to comment on Mint’s query.

Queries sent to the health ministry spokesperson remained unanswered till press time.

Quality control

These poor quality and unsafe medicines have been reported by the drugs inspector, East Zone, CDSCO, that has a mandate to pick samples to ensure that genuine product is available in the market.

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During 2022-23, at least 3,053 drugs were found substandard and 424 spurious or adulterated, Union minister of state for health and family welfare Anupriya Patel said in Parliament in July.

Earlier in February, the apex drug regulator instructed the states/Union Territories to keep a strong vigilance and surveillance on the quality of drugs available in the market by doing random sampling of the medicines. The initiative helps create a monthly database of spurious and NSQ medicines and keep a check on manufacturers.

Another important drug, Defcort 6 Tablets, have been found to be unsafe by the Delhi drug regulator. The indication is used to treat Duchenne muscular dystrophy (DMD), a rare health condition.