DCGI finds Paracetamol among 50 medicines to be substandard

The drug regulator has found 50 lifesaving medicines, including those used to control fever and seizure, to be of sub-standard quality across India.

The long list of such drugs includes Paracetamol 500 mg, Telmisartan anti-hypertension drug, Cuftin cough syrup, Clonazepam tablets used to manage seizures, anti-pain relief drug Diclofenac, multi-vitamins and calcium tabs.

Henna misbranded

Also, the drug regulator has found that commonly applied Henna mehndi is also of poor quality and misbranded as per provisions laid down under the cosmetics category.

This comes even as India’s pharmaceutical sector is under a scanner after cough syrups made in the country were linked to the deaths of children overseas.

According to a Central Drugs Standard Control Organisation (CDSCO) drug alert for May, the drug samples were picked from Waghodia (Gujarat), Solan (Himachal Pradesh), Jaipur (Rajasthan), Haridwar (Uttarakhand), Ambala, Indore, Hyderabad, and Andhra Pradesh among other states.

Paracetamol 500 mg. tablets, which have been found to be sub-standard, are manufactured by Askon Healthcare based in Ujjan, Madhya Pradesh. The firm, on its official website claims that it has been manufacturing pharmaceutical finished dosage form. 

Phone calls and email queries sent to the Askon Healthcare remained unanswered.

DCGI list

Other medicines on the list of DCGI include lactulose solution used to treat constipation, anti-hypertension drug Telmisartan and Amlodipine IP tablets, Dexamethasone SodiumPhosphate Injection I.P used to manage auto-immune dieaseas and serious infections and Clonazepam TabletsI.P.0.5mg which used for treating neurological complications. 

The drug samples were examined at both Central and state laboratories.

Earlier in February, the Drug Controllers General of India (DCGI) Rajeev Raghuvanshi instructed states/UTs to keep a strong vigilance and surveillance on the quality of drugs available in the market by doing random sampling of the medicines. 

This initiative is helping to create a monthly database of spurious and substandard medicines and keep a check on manufacturers.

Health minister JP Nadda directed officials to ensure the safety and quality of medicines in the country.

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

Also read | Organ transplant rules: Health ministry urges MHA, MEA to educate foreigners