DRA napping as spurious drug sales continue unabated

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Islamabad: Drug Regulatory Authority (DRA) has asked the provincial authorities to furnish an investigation report to take legal action against M/s Everest Pharmaceuticals Pvt Ltd, which is allegedly involved in the manufacturing of unregistered medicines with uncommon formulations/combinations, it was learnt.

Ironically, manufacturing and sale of medicines with unique, uncommon and multiple brands of one molecule is allegedly continuing in the country as reportedly various local and international pharmaceuticals companies are found involved in this business. Due to lack of effective check and balance by the regulatory authority, the pharmaceuticals companies are playing with precious human lives to gain some monetary interests. M/s Everest Pharmaceuticals Pvt Ltd is an Islamabad based company and is allegedly involved in this heinous business.

On finding a complaint regarding registration of unique/uncommon combinations and multiple brands of one molecule of M/s Everest Pharmaceuticals Pvt Ltd, Drug Regulatory Authority (DRA) has asked all provincial chief drug inspectors including Punjab, Baluchistan, Sindh, Khyber Pakhtunkhwa, Gilgit-Baltistan, and chief commissioner, Islamabad Capital Territory (ICT) to forward a comprehensive investigation report to take legal action under the Drug Act, 1976 and respective rules for further necessary action. DRA further requested to all the said chief inspectors and chief commissioner to ensure that no un-registered product is available in the market and or illegally manufactured in violation of the Drug Act, 1976 and DRAP Act 2012.

Copies of official documents further transpire that M/s Everest Pharmaceuticals Pvt Ltd, Islamabad is involved in the manufacturing of un-registered products/combinations (formulations) from last few years as DRA in a letter dated 03rd December 2015 had asked all concerned chief drug inspectors to conduct assessment through FIDs pertaining to the availability of manufacturing of unregistered products of M/s Everest Pharmaceuticals Pvt Ltd. The DRA also sent reminders to the concerned authorities (chief drug inspectors) to take appropriate action as per law.

A DRA’s list pertain to the products/medicines with unique formulations/combination manufactured by M/s Everest Pharmaceuticals Pvt Ltd include the product brand names as Everlong (Dapoxetine 60 Deregistered), Esper 40/30 (Esomeprazole + Domeperidone), Sankol Plus 200mg/2mg (celecoxib+Tizanidine), Penboll Plus 300mg/100mg (Gabapentine + Mecobalamine), Syrup MT.D (Montelukast+Desloratadine), Tab Chill (Piroxicam+Tizanadine), Tab.M.Plus (Montelukast+ Levocetirizine 2HCL) and Tab Samprid (Esomprazole + Cenitapride).

Pointing out the multiple brands of one molecule available in country’s market at high price and manufactured by M/s Everest Pharmaceuticals Pvt Ltd, the DRA has asked the provincial Chief Drug Inspectors to take suitable action as per law against the availability and manufacturing of the Capsule REAP with generic name Letrozole 2.5mg, Tablet LINK (Letrozole 2.5mg), Capsiule SILK (Letrozole 2.5mg) and Tablet LEENA with generic name Letrozole 2.5mg.

Documents also reveal that the above formulations have been verified from the official record/minutes of the meeting of the registration board which is the structured body for registration of drugs in Pakistan under the law. This verification has confirmed that none of the above formulations/combinations is approved by the registration board and thus are unregistered and or illegally manufactured in violation of Drug Act 1976 and DRAP Act 2012 and the rules framed in this regard.

Background interviews and discussions conducted with doctors and medicine specialists revealed that above said medicines with uncommon formulations/combinations are harmful for the human body. These medicines are being used to arouse sexual desire as these are aphrodisiac. These medicines are harmful upon use for kidney, lungs, liver etc. And, all those people who use these drugs might fall victim to many fatal diseases. More, these medicines with unique/uncommon combinations/formulations and multiple brands of one molecule are freely available in the open market.

“Though pharmaceutical companies are playing with human lives, however, DRA is sleeping in deep slumber as sale and manufacturing dozens of unregistered medicines are continued in the country for a long time,” they said.