LAHORE: The Punjab government has approached the Drug Regulatory Authority Pakistan (DRAP) with a request to cancel/suspend licences of 10 pharmaceutical companies and also sought permission to proceed against them for not meeting the good manufacturing practices (GMP). A set of recommendations (for DRAP) was prepared on the basis of lab test reports of drugs, frequent inspections and inquiries into serious complaints surfacing against the manufacturers.

Most complaints reported against the in-question pharmaceutical firms were related to the manufacturing, selling and supplying of substandard medicines.

Pointing out a serious blunder by a pharmaceutical company, the Punjab authority claimed that water for injection was treated and stored in an open steel tank, leaving it non-sterile.

Lab reports find firms manufacturing and supplying substandard drugs

Another firm was found manufacturing drugs from expired Active Pharmaceutical Ingredient. Of the 10 firms, seven companies are based in Lahore and others in Faisalabad.

The Punjab government asked the DRAP to take action against them under the Drugs Act 1976 in respect of cancellation or suspension of drug manufacturing license.

The government, in its recommendations, also sent a set of findings related to violations committed by the firms during manufacturing of drugs.

“The M/s Lahore Chemical & Pharmaceutical Works has been stocking/manufacturing drugs from expired Active Pharmaceutical Ingredient”, the government report says.

It said that the M/S Drug Pharm (Pvt) Ltd has been storing raw material under the uncontrolled condition. It has not maintained the record properly, machines were working under bad/unhygienic conditions and flooring of the syrup section was not up to the mark.

About the M/S Aneeb Pharmaceuticals (Pvt), Lahore, the report says, there were no overalls, shoe, covers, masks, or gloves available at the entrance and most of the workers were also not wearing overalls and gloves.

The firm had not properly maintained the raw material store. The active raw material was stored without ‘release labels’ and temperature control.

Temperature and humidity record were not maintained and air-conditioning and the HVAC system were not functioning.

The equipment and instruments of quality control had not been labeled and calibrated. The firm was manufacturing drugs without controlled temperature conditions.

M/S Mediways International, Lahore, was involved in illegal or unauthorized import of raw material without label (misbranded), the report says.

M/S Orta Laboratories (Pvt), Lahore, has not been maintaining temperature and humidity record while the storage was found without label and record.

The report says that M/S Redex Pharmaceutical Industries (Pvt) Ltd, Faisalabad, was found involved in manufacturing of spurious drugs besides facing serious complaint of expiry date on drugs. The qualified person was also not available there.

M/S Sanna Laboratories, M/S BJ Pharmaceuticals, M/S Axix Pharmaceuticals and M/S Perfect Pharma have been issuing false warranty besides manufacturing/stocking and selling misbranded and substandard drugs, the report says.

It also mentioned percentage of the substandard drugs being manufactured and supplied by these four firms that was reported between 54pc and 13pc.

The batch numbers were also mentioned against the manufactured drugs.

Commenting on the issue, senior pharmacist and legal expert Dr Noor Mohammad Mehar demanded reforms to ensure production of quality medicines on affordable princes.

He criticized the government for not introducing a ‘foolproof system’ to check quality of medicines saying that under the prevailing circumstances the drug inspector alone was responsible to ensure standard medicine.

Pakistan Pharmaceutical Manufacturers Association Chairman Chaudhry Yusuf strongly condemned the government decision, saying that it would adversely affect the national industry’s growth.

He said the PPMA called a meeting on Friday which noted that no laid-down policy was followed to take manufacturers on board before taking any extreme step against them.

“The government functionaries should first issue show-cause notices and then adopt a due process to prove the allegations”, Chaudhry Yusuf said adding that unfortunately nothing was done before seeking DRAP action.

He said that the national pharmaceutical industry met the 90 per cent market demand for drugs which was sufficient to prove that the local manufactures were producing quality medicines.

Published in Dawn, August 20th, 2016