Action initiated against firms for more salt in de-addiction drug

Vishav Bharti
Tribune News Service
Chandigarh, October 30

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The Punjab government has started action against the drug companies whose de-addiction drug buprenorphine was found containing more quantity of salt than the legally permissible limit.

According to government officials, the state government has sent the investigation reports of the companies to three states where manufacturing units of these companies are located.

On October 17, The Tribune had highlighted that how the de-addiction programme in the state may be on the path to introduce a completely new addiction as it had been found that the drug de-addiction drug was found containing up to 25 per cent more of the active salt than legally allowed. There are just four major suppliers of the salt, buprenorphine, in Punjab, selling under different brand names.

The state’s Food and Drug Administration had found that the medicine from two of these suppliers contained 17-25 per cent more salt than allowed, while one had below the dose given on the label.

Staish Chandra, Additional Chief Secretary, Health, confirmed the development. He said one of the companies challenged the findings of the state laboratory. So as per the set protocol, their samples had been sent to Central Drugs Laboratory (CDL) Kolkata, which was an appellate laboratory.

Sources said the state government had sent the investigation reports to the states from where these companies run their manufacturing operations.

Rusan Pharma (Addnok-N) operates from Uttrakhand, Maan Pharmaceuticals (Cizdol-N) from Gujarat and SBS Biotech (QTRUGS) from Haryana. The state government has written to their respective states.

As mentioned on the strips of Addnok-N, the quantity of buprenorphine should not be more than 2 mg per tablet. However, it was found to contain around 25 per cent more than that. Similarly, Cizdol-N contained 17 per cent more. On the other hand, QTRUGS-0.4 was found to contain 14 per cent less than the dose mentioned. As per the Drugs and Cosmetics Rules, 1945, the buprenorphine salt cannot vary more than 10 per cent of the dose mentioned. If it happens, a legal action can be initiated against the manufacturer.

Earlier, fearing that more dose of medicine can vitiate the entire de-addiction programme, the state government had even recommended suspension of sale of the particular medicine by the three drug companies.