Asia Regulatory Roundup: Pakistani Manufacturers Shut Down in Protest Against Regulatory Amendment (18 August 2015)

Posted 18 August 2015 By Nick Paul Taylor

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

Pakistani Manufacturers Shut Down in Protest Against Regulatory Amendment

Members of the Pakistan Pharmaceutical Manufacturers Association (PPMA) have shut down their units in protest against regulatory changes. The actions were later postponed following the death of a politician, but PPMA still has grievances with government plans to hand out 10-year prison terms for manufacturers of substandard medicines.

By Sunday, 16 August, the dispute had escalated to the point that more than 70% of pharma units had been closed, Khawaja Shahzeb Akram, former vice chairman of PPMA, told The Nation. The rest were due to close the following day. Akram thinks the amendments to the Drug Regulatory Authority of Pakistan Act (DRAP), 2012 conflate substandard and counterfeit drugs, leading to the setting of punishments for the former that are more commonly associated with the latter.   

Another former PPMA leader, Amjad Ali Jawa, compared the conflation as equivalent to handing out the same punishment for road accidents and murders. Manufacturers in Pakistan are insulted by the amendment and concerned that honest mistakes that in most markets would land them with a fine will see their executives put in jail. In response, PPMA has mounted an aggressive protest and told the government to get its own house in order.

“Our association has decided to hand over keys of factories to Punjab government as they are unable to work in this atmosphere. Now [Chief Minister of Punjab] Shahbaz [Sharif] and its cabinet should run the industry,” Akram said. The former PPMA official also said the government should focus its energies on making DRAP stronger and more transparent, notably by proactively monitoring the quality of medicines and taking appropriate actions against producers that fall short of standards. 

The Nation, More

Indian Economic Committee Approves $270M Regulatory Investment Plan

The Indian Cabinet Committee on Economic Affairs (CCEA) has signed off on a proposal to invest in national and state regulatory infrastructure. Having received the blessing of CCEA, regulators are set to split a pot of Rs 1,750 crore ($269 million) that the government will release over the next three years, the Press Trust of India reports.

National-level regulators will pick up Rs 900 crore, with their peers in the Indian states sharing out the rest. The money is earmarked for a wide range of improvements, which collectively are intended to give India a regulatory system befitting the prominent role the country plays in drug testing and manufacturing. New drug and medical device testing laboratories are planned, while existing sites are also due to be improved through the addition of new equipment and increases to headcount.

The need for such improvements has been discussed for years without the problem ever being fully addressed. Now, state and national regulators are set receive the cash they need to enact changes. Government officials also want regulators to use the money to prepare for the future. The setting up of regulatory infrastructure for stem cells and regenerative medicines, as well as more established fields such as biologics, drugs and medical devices, is on the agenda. 

Regulators are also expected to use the money to continue moving their operations online. “The upgradation will also introduce organization wide e-governance and information technology enabled and online services and setting up a training academy for regulatory and drug testing officials of both the central and state governments,” the government said in a statement.

Press Trust of India

Indian Policy Institute Recommends Capping Cardiac Stent Prices

An Indian organization tasked with supporting policy development at the Ministry of Health has come out in support of the capping of the prices of cardiac stents. The National Health Systems Resource Centre (NHSCRC) detailed its views in a report to the ministry, The Economic Times reports.

While NHSCRC only has the power to recommend changes, its support is still a boon for the drive to regulate the prices of medical devices in India. NHSCRC has proposed capping the prices of bare metal and drug eluting stents at Rs 19,000 ($292) and Rs 28,000, respectively. Both figures fall within the range of prices for which the products are sold today, something NHSCRC has achieved by basing its numbers on those provided by manufacturers.

Capping the price at such a level should, in theory, allow manufacturers to receive a fair price while preventing patients from paying dramatically more than the factory cost for their stents. The issue of stent pricing was pushed to the fore by a report from Maharashtra Food and Drug Administration (FDA) that found patients were paying 240% more than the import cost by the time each player in the local supply chain had taken their profits.

The price cap policy is expected to face opposition from parts of the industry if the government tries to enforce it. Multinational manufacturers reportedly think any price cap that fails to take the perceived superiority of their products to those of local rivals into account is unfair.   

The Economic Times

Bangladeshi Court Sentences Pharma Execs to 10-Year Jail Terms for Paracetamol Poisoning

A court in Bangladesh has sentenced six pharmaceutical executives to 10 years in jail for their roles in the production of a toxic paracetamol syrup. The events date back to the early 1990s, when a rise in kidney failure among children led to investigations into products made by BCI Bangladesh.

Prosecutors filed a case against the now-defunct BCI back in 1992, but it has taken 23 years for three directors and three managers from the company to be sentenced. Each of the defendants faces 10 years in jail, plus a further six months if they fail to pay a fine of Tk 200,000 ($2,569). However, five of those charged, including BCI’s production and quality control managers, are on the run, meaning only one of the former directors will receive his punishment immediately.

The case relates to the use of diethylene glycol, a chemical used in the leather industry, instead of the more expensive propylene glycol as a solvent in paracetamol syrups. Cases of such substitution have occurred around the world in recent decades, and for a period it was a widespread problem in Bangladesh. Officials have brought cases against five companies, while some local physicians think the use of diethylene glycol dates back to the 1980s and could have killed thousands of children.

AFP, The Financial Express

Other News:

China has released further details of its new strategy for the review and approval of drugs and medical devices. The lengthy document covers actions China plans to take to slash its backlog of applications, improve the quality of generic drugs, accelerate the review of innovative medicines and raise the standard of clinical trials. CFDA Notice (Chinese)

The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has posted guidance on how wearers of colored contact lenses can avoid eye infections and other diseases. PMDA is promoting its guidelines on billboards around Tokyo’s Shibuya Station in an attempt to curb the incidence of eye infections. Surveys have found such infections are common among teenagers. Japan Times

India has banned the over-the-counter sale of nonsteroidal anti-inflammatory drugs (NSAIDs). The move to make aspirin and other products prescription only is intended to stop people with Dengue from worsening their condition through the use of NSAIDs. Press Trust of India

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Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Japan, China, Taiwan, Korea, India, Asean, Oceania, PMDA, CFDA, CDSCO

Tags: Asia Regulatory Roundup, Regulatory Roundup

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