Islamabad - Ministry of National Health Services on Wednesday granted licences to as many as 23 local pharmaceutical manufacturers while rejected one for failing inspection.

A statement issued here said that 23 local manufacturers who passed the inspection were granted enlistments whereas one manufacturer who failed the inspection was denied the licence.

The statement said that all pending cases had been cleared and to facilitate quality products, it had been decided that all local and imported manufacturers be advised to produce at least three trial batches and submit actual formula and test results to speed up scientific evaluation. The decision will ensure that only quality products with actual data will be enlisted to help eliminate spurious or substandard drugs from the market.

In this regard, local manufacturers will be assisted to acquire quality raw material and technical help will be provided to them during the formulation process. The data submitted by the firms will be distributed to the enlistment committee members to facilitate early disposal of cases, the statement added.

Further, the committee suggested revising the application forms to make the same more product-specific and revise checklist accordingly. Services of government laboratories such as PCSIR will be used to test raw herbs for proper identifications, the statement said.

Meanwhile, the Drug Regulatory Authority of Pakistan denied allegations levelled by Pakistan Young Pharmacists Association (PYPA) and Pakistan Drug Lawyer Forum (PDLF).

In a desperate attempt to gain vested interests and pressurise officials of the DRAP, these elements are disseminating wrong and misleading information to divert the focus of regulators and investigation agencies from their heinous crimes, the statement also said. The Ministry of National Health Services and the DRAP refuted the allegations as factually incorrect, baseless and totally misleading for vested interests, the statement added.

These elements are aggrieved due to improvement in functioning system of the DRAP in line with international regulatory practices and numerous campaigns running to eradicate spurious, fake and illegal drugs from the country, the statement said.

The Supreme Court upheld decision of the DRAP regarding cancellation of the registration of RBST hormones and vacated the stay granted in this respect by Sindh High Court. Accordingly, the Division of Quality Assurance, DRAP issued directives to its field offices, provincial governments and their inspectorates and administrations of ICT, AJK and Gilgit-Baltistan to take stern action against sales of the RBST hormone being used to increase milk production in cattle, the statement added. The federal inspectorate and provincial inspectors are conducting raids in line with the directions and have seized stock of the banned injections.

However, certain elements are deliberately trying to confuse cancellation of registration of the RBST with other drugs, oxytocin in particular, which is used in cattle and pets for precipitation of labour and to control uterine haemorrhage, it said.



our staff reporter