Asia Regulatory Roundup: Pakistan Proposes Strengthening Quality Control Unit Requirements (14 November 2017)

Posted 14 November 2017 By Nick Paul Taylor

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Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Pakistan Proposes Strengthening Quality Control Unit Requirements

Pakistan is planning to strengthen the requirements it places on the quality control departments of drug manufacturers. The revised legislation raises the minimum level of experience required to run a quality control unit and mandates the appointment of an independent head of quality assurance.

In its current form, Pakistan's Drugs (Licensing, Registering and Advertising) Rules, 1976 requires companies to have a quality department independent of their manufacturing units and provides a vague outline of the qualifications and experience its staff must possess. The proposed changes build on this platform by clarifying and increasing the minimum requirements for employment.

If the changes come into force as planned, quality control units will need a full-time employee who has either a degree in pharmacy and "six years experience in testing of types of drugs intended to be manufactured" or a "master degree in science with chemistry" and 10 years of experience. Unlike the current law, the proposed text does not allow for the employment of people with degrees in medicine.

The changes also clarify the requirements for quality control units that perform pharmacological and microbiological testing. These topics are touched on in the current law but the new version goes further by stating units need an additional employee to perform either type of test. In the case of pharmacological testing, that person should have a degree in pharmacy or master degree in pharmacology and at least six years of experience. For microbiological testing, the baseline is a degree in pharmacy or a master degree in microbiology and six years of experience.

Legislators also want to add a paragraph mandating the employment of an independent head of quality assurance with a degree in pharmacy and seven years of experience. Five of those years must have been spent in quality control and drug testing.

Pakistani officials proposed the changes alongside other amendments to the conditions companies must meet to secure a license, or renew of an existing license, to manufacture drugs.

Legislative Amendments

DCGI Demands Fake Drug Vigilance After Approval of AstraZeneca Cancer Medicine

The Drug Controller General of India (DCGI) has told his staff to look out for counterfeit versions of AstraZeneca's drug Tagrisso. DCGI Dr GN Singh issued the notice to urge staff to remain vigilant now AstraZeneca has gained clearance to sell the non-small cell lung cancer (NSCLC) drug in India.

Singh first contacted regulatory officials about counterfeit Tagrisso last month. At that time, India was yet to approve Tagrisso but products purporting to contain the active ingredient, osimertinib, were already being sold under various brand names online.

The October memo stated Tagrisso was yet to win approval in India and urged regulators at ports and other offices to find and intercept fakes.

Singh's new notice withdraws the earlier memo as Tagrisso is now approved for use in patients with metastatic epidermal growth factor receptor T790M mutation-positive NSCLC. However, Singh wants regulators to remain on alert for counterfeit versions of the drug.

Approval of Tagrisso in India comes two years after AstraZeneca won accelerated approval of the drug in the United States.

DCGI Notice

DRAP Hits Back Against 'Drug Mafia' After Corruption Allegations

The Drug Regulatory Authority of Pakistan (DRAP) has bit back against allegations of corruption. DRAP said the claims were baseless and motivated by pockets of resistance to 2D barcodes and other aspects of its reforms.

Officials published the statement in response to a press release and conference orchestrated by the owner of Everest Pharmaceuticals and people DRAP called his associates at the Pakistan Drug Lawyers' Forum (PDLF) and Pakistan Young Pharmacist Association (PYPA). PDLF and PYPA accused DRAP of working to raise the profits of multinational companies at the expense of local firms and of improper hiring practices.

DRAP sees things differently. In a strongly-worded statement, the agency makes counterclaims against its accusers and defends itself against what it sees as the latest in a series of "defamation attempts, character assassination [and] fake complaints" by members of the "drug mafia." As DRAP tells it, these accusations surface whenever it and other agencies try to raise standards and stamp out certain activities.

The war of words is part of a series of rows in the media between DRAP and its critics. This series peaked in the run up to the appointment of DRAP's CEO in 2015 but PYPA and others have kept making accusations of wrongdoing at the regulator since then.

DRAP Statement, Daily Times, The Express Tribune

NPPA Gives Stent Manufacturers Until End of 2017 to Comment on Pricing

India's price watchdog has given manufacturers and importers of coronary stents until the end of the year to comment on the price cap on their products. The National Pharmaceutical Pricing Authority (NPPA) is seeking the comments to guide its reassessment of the price ceiling early next year.

Multiple companies have pushed back against the price cap since NPPA implemented it earlier this year. In a recent memo, NPPA chairman Bhupendra Singh said the agency has already "received some representations with regard to pricing" but is still accepting feedback. The cutoff date for submissions is 31 December.

Singh and his colleagues will factor the feedback into their upcoming reassessment of the price of coronary stents. NPPA will consider whether to change the price ceiling in January and February, one year after they set the current cap.

In setting the original cap, NPPA opted against allowing the sellers of new, purportedly better stents to charge more. That proved to be one of the more controversial aspects of the price cap, although it is questionable whether any data has been generated over the past 12 months that will make NPPA reconsider its position.

NPPA Memo

India Establishes New Process for Submission of Information

India has established a new process for the submission of data and other information to regulatory officials. All submissions must now go through an employee at the headquarters of the Central Drugs Standard Control Organization (CDSCO).

That employee, Dr Ravi Kant, will then forward submissions on to the relevant department.

Prior to the adoption of the new model, some companies were sending information intended for the Ministry of Health and Family Welfare and other departments to regional offices of CDSCO, cutting the headquarters out of the loop.

The potential for CDSCO to be unaware of submissions and for them to get lost in the system prompted the regulator to adopt — and urge compliance with — the new way of working.

CDSCO Order

Other News:

The Therapeutic Goods Administration (TGA) of Australia has alerted consumers and healthcare professionals to the recall of an Apotex product. Apotex is recalling the cardiovascular medicine, Apo-Perindopril Arginine, after discovering the contamination of some bottles with dark particles of silica. The particles are thought to come from the desiccant cylinder used to keep the tablets dry. TGA sees the issue as a quality, not safety or efficacy, problem. TGA Notice

TGA is "urgently working" with the manufacturer of defibrillator electrodes for use on children to address a problem with the product artwork. The artwork on the electrodes shows the wrong part of the body on which to use the device when treating an infant. Incorrect use of the electrodes could cause serious injury or death. TGA Alert

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Quality, Submission and registration, News, Asia, Oceania, CDSCO, TGA

Tags: Asia Regulatory Roundup, Regulatory Roundup

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