Nine Pharma Firms In Dock As De-Addiction Drugs Fail Test

Chandigarh, 6 Feb 2020:

The de-addiction programme in the state has come under the scanner, as the samples of a majority of the medicines being sold in Punjab for drug de-addiction have failed quality test.

Sources say as per the recent tests conducted at State Drug Testing Laboratory by the Food and Drug Administration, the amount of salt in the medicine of nine manufacturers were found much less than the prescribed limit. Buprenorphine and naloxone are the two main salts that are being used to treat the heroin addicts in the state.

As per the Drugs and Cosmetics Rules, 1945, buprenorphine and naloxone salt cannot vary more than 10 per cent of the dose mentioned on the strip. However, there are cases in which the variation is around 40 per cent.

The sources say some of the main manufacturers whose drugs have been found “not of standard quality” are Rusan Pharma, Maan Pharmaceuticals, Arbour Biotec, Omega Pharmaceuticals, Ben Pharmaceuticals, Perk Pharma Pvt Ltd, Cooper Pharma and Micron Pharma. According to an estimate, all these companies together have over 90 per cent share in the entire private de-addiction programme.

The FDA had collected samples from various de-addiction centres. There are around 25 centres that may also face action.

The sources say the government has placed these medicines in “Not of Standard Quality” category. And the manufacturers may face cancellation of the licence as the Punjab FDA has written to the states where these manufacturers are based, asking them to take action.

This is not for the first time that drugs from Rusan Pharma, Maan Pharmaceuticals and Arbour Biotec have failed the quality test. Last year, the FDA had found that the de-addiction medicines being manufactured by these companies contained salt far more than the prescribed limit. Their analysis confirmed that the medicines contained 17-25 per cent more salt than allowed. The FDA had initiated prosecution of these companies in the court.

Buprenorphine is prescribed as per a specified protocol. And if the drug contains more or less than the dose, the entire protocol is vitiated, notes the government communication.

A senior PGI pharmacology expert, who wished not to be named, said it was common knowledge that if the salt was less it meant the drug was less potent and could not only be ineffective but could be misguiding for the physician. “If the medicine is less potent, the chances of relapse of the patient are greater. It has the potential to harm the entire programme,” he said.

Interestingly, one of the few companies that has passed the quality test was supplying medicines to government de-addiction and outdoor opioid treatment centres even as private centres have been making hue and cry that the medicines being dispensed in government hospitals and OOAT centres were poor quality. The Tribune