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Regulatory News | 25 November 2014 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, a new weekly overview of the top regulatory news in Asia, the Middle East and Oceania.
The Indian government is planning to amalgamate all departments and agencies involved with overseeing the pharmaceutical industry into a single organization, according to news reports. Officials hope the move will make the regulatory system more effective by increasing coordination between its different strands.
As it stands, the Ministry of Health and Family Welfare oversees the Central Drugs Standard Control Organisation (CDSCO), while the Ministry of Chemicals and Fertilisers is responsible for the National Pharmaceutical Pricing Authority (NPPA). The government is questioning the wisdom of splitting oversight of the bodies responsible for approving and pricing drugs between two ministries.
The proposed structural changes are part of a broader rethink of the government’s approach to the pharmaceutical industry. “We are working on a comprehensive pharma policy to usher growth in this sector. Under this policy we are focusing on three areas: Bulk drugs, medical implants and medical devices,” Minister of Chemicals and FertilisersAnanth Kumar told the Press Trust of India.
Parliament is set to debate some of the proposed changes. The Central Drugs Authority (CDA) bill is due to be introduced in parliament in the coming months, PharmaBiz reports, more than one year after it was first discussed. The progress of an earlier version of the bill stalled after some proposed changes were deemed unacceptable.
Changes proposed in the current version include stripping state officials of responsibility for vaccine production licenses. The new text also covers medical devices, but full details are yet to emerge.
PT I I PharmaBiz
The Pakistani pharmaceutical industry has backed plans to set up a reference pricing system. Industry officials say the model — which is based on prices in countries similar to Pakistan — is the most transparent and fair of the three options presented by the Drug Regulatory Authority of Pakistan (DRAP).
DRAP has reportedly met with industry groups to discuss a pricing policy that the Sindh High Court wants to have finalized as soon as possible. Pharmaceutical manufacturers — particularly multinational businesses — have criticized the current situation for being inconsistent and too reliant on interim agreements. Representatives of multinational trade group Pharma Bureau told the pricing panel the situation is driving companies out of Pakistan, the news organization DAWN reports.
Pharma Bureau, Pakistan Pharmaceutical Manufacturers Association (PPMA) and Pakistan Chemists and Druggists’ Association (PCDA) all backed a move to reference pricing, although each has different concerns with the details and the process. Pharma Bureau wants to limit price controls to a small number of drugs, while PCDA has criticized DRAP for excluding certain groups from the talks and for failing to finalize its policy by the date set by the Sindh High Court.
The case of Gilead’s hepatitis C blockbuster Sovaldi shows some of the problems with the current system. Gilead’s partner in Pakistan, Ferozsons Laboratories, agreed a price with DRAP this week, one year after the registration process began. DRAP has been criticized for the time it took to register and a agree a price for the drug.
DAWN I More I Sovaldi News
An investigation into the deaths of 13 women at an Indian sterilization camp has confirmed the drugs they received were contaminated with a poisonous substance. Earlier reports said the substance was zinc phosphide, a chemical used to kill rats.
The state government has suspended the licenses of two manufacturers that supplied drugs to the camps and withdrawn their products from health centers. Investigations into how the companies were able to supply the camps despite previous quality control violations are now underway.
Newspapers in India and overseas have criticized the regulatory environment that allowed the firms to continue manufacturing drugs. The Financial Times led the international coverage, detailing how thousands of tiny manufacturing operations supply drugs to Indian health centers.
“India has a generic drug industry that makes the best quality medicine and exports it to the rest of the world, but then those medicines are not reaching Indian patients,” an anonymous official told the newspaper.
PTI I PharmaBiz I Indian Express I Financial Times
The total lack of a government regulation of pharmaceuticals in Afghanistan has created a major opportunity for manufacturers in neighboring Pakistan. Around half of all medicines in Afghanistan were either smuggled into the country or produced by substandard Pakistani manufacturers.
A committee set up by the Afghan government and the international community cited the figures in a report on the local pharmaceutical sector, the Associated Press reports. As many as 300 companies in Pakistan are manufacturing substandard drugs exclusively for sale in Afghanistan, according to an Afghan government report. The government of Afghanistan does not regulate pharmaceuticals or medical devices, the AP notes.
The committee has called on the government to start regulating the sector. Until that happens, a sizable market is likely to remain in the hands of substandard manufacturers. “The market for imported pharmaceuticals here is between $700 million and $800 million, and more than half of it is illicitly imported drugs,” Eva Joly, the head of the committee, said.
The Indian Drug Manufacturers Association (IDMA) has escalated the row over a proposed ban on polyethylene terephthalate (PET) containers by warning it will cause drug prices to rise by up to 30% and could lead to shortages.
IDMA President SV Veeramani made the claims to the Economic Times in comments that included a barrage of figures to support the trade group’s case against the government. Veeramani said the ban will force manufacturers to use glass, increasing demand for the material by 900,000 metric tons a year. The surge could cause drug shortages if the supply of glass fails to keep up with demand.
Veeramani expects the drugs that are sold to be more expensive. The price of glass, which already costs more than PET, could increase as demand rises. Glass bottles also incur higher transport costs than PET because fewer can be shipped in each container and thicker outer packaging is needed. The government argues health issues mean PET is unsuitable for packaging certain products.
Australian and New Zealand officials have scrapped plans to merge their regulatory systems. The Australia New Zealand Therapeutics Products Agency (ANZTPA) was due to become fully operational in 2017, but is no longer viewed as cost-effective. At this stage it is unclear what will happen to active ANZTPA harmonization programs. Regulatory Focus
The Chinese government is considering adopting tougher regulations on tobacco, but has already reportedly toned down the draft in the face of intense lobbying. Reuters reports a lobbying campaign by the state tobacco monopoly has succeeded in getting an outright ban on advertising removed from the proposals. Tobacco taxes totaled $131.7 billion last year. Reuters
TGA has released warnings about two medical devices. The Australian regulator worked with Boston Scientific to warn healthcare professionals about a temporary malfunction with Autogen DR Implantable Cardioverter Defibrillators and Autogen Cardiac Resynchronisation Therapy Defibrillators. Medtronic also issued a warning about its 3f Enable Aortic Bioprosthesis. TGA I More
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