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Zimbabwe’s regulatory bureaucracy is a major deterrent to pharmaceutical investors who want to set up shop or bring goods to the country, industry stakeholders have said.

Participants at the Pharmaceuticals Export Promotion Council of India (Pharmexcil) 2014 here have mostly expressed interest in the country but said there was need to change the country’s regulatory framework.

According to some, it takes two to five years to get approval from the authorities such as the Medicines Control Authority of Zimbabwe for a drug to make its way to the country’s market while the fees charged are double those prevailing in the region.

Buyers from Zimbabwe also said they had lost out on investment as there was a lot of bureaucracy around giving approval for drugs.

This, they said, was making the country unattractive because it already was at a disaantage because of its relatively small market.

At a technical seminar to discuss the role of regulators in pharmaceutical investments, Mr Sudhanshu Pandey — India’s joint secretary for commerce and industry — called for synchronisation and harmonisation of regulatory laws in the developing world.

“This is in line with international norms. Harmonisation would ensure seamless trade. Bear in mind too that no regulatory regime is superior or inferior as they all share the history of science. The arching objective is to serve people in an efficient manner,” he said.

He added that the current regime in developing countries impeded innovation.

“Some of the regulations are not clear or are just silent about innovation. When one creates a game changing molecule, does the regulation recognise this?

“A poor regulatory framework is a barrier to trade and investment,” he said.

Mr Pandey noted that there were many multi-layered departments involved in regulation and this pushed up the cost of the final product and service to the consumer.

“However, if the regulatory framework is unified, it will reduce the time a drug gets to the market and at the same time reduce costs. It also kills the black market.”

He stressed that regulations should not in any way compromise the safety and quality of drugs.

Mr Shigeru Toyoda, an international co-operation aisor with the Osaka Pharmaceutical Manufacturers Association of Japan, said on average the world had a 2,5 year lag with the major drug manufacturer, the United States, mainly due to lengthy registration procedures and clinical tests.

Greenwood wholesale operations manager Ms Valerie Musere said Zimbabwe’s pharmaceutical industry was presently by the liquidity challenges facing its major clients.

“Supplying to the public service is currently difficult as Government is not paying while the other major customers, the medical aid societies, are also falling behind on their obligations,” she said.

With over 500 companies and regulators participating at Pharmexcil 2014, India is reinforcing its standing as the dependable and affordable generics pharmacy of the world.

Pharmexcil chairman Mr Ashutosh Gupta said Indian generics reach almost all corners of the world with over 50 percent of the $16 billion products being shipped to highly-regulated markets.

Source : The Herald

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