ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) rejected nearly 2,500 applications to register alternative medicines in the last three years.
Alternative medicines include Ayurvedic, Chinese, Unani, herbal and homeopathic medicines.
Drap Director Dr Obaidullah told Dawn that three years ago, 3,500 manufacturers and importers submitted applications under the Alternative Medicine and Health Products (Enlistment) Rules 2014.
“Although the applications were received they had to be analysed in two steps. The first was the registration of companies. Some companies, which lacked the capacity for manufacturing were also rejected for the enlistment of products. Some companies lacked documentation in their applications and others were not meeting the minimum standards for the factory area,” he said.
“A number of applications were rejected because of the lack of good manufacturing practices (GMP). They had a number of deficiencies, and allowing such companies to manufacture medicines would have been a step to compromise the health of the people,” he said.
In response to a question, he said that all the companies that had asked for permission to export medicines had been allowed to do so, and there were currently no pending export cases.
Companies that are not allowed to sell in Pakistan cannot export their medicines, he added, as this could compromise the country’s reputation.
“If any company has any complaint regarding the delay in granting export permits, it should contact Drap and their issue will addressed without delays,” he said.
Last week, Transparency International-Pakistan wrote to Drap pointing out irregularities in the authority. It claimed that alternative treatment systems have been regulated in Pakistan for the first time and require periodic assessments and progress by the competent authority for immediate decisions.
Since 2014, inconsistent policies and unnecessary delays in the issuance of no-objection certificates and free sales certificates have led to a fall in exports.
It was also alleged that the delaying tactics had opened the door to massive corruption, and those who had applied for Form-7 (provisional certificate for enlistment of products) were still waiting, while favoured manufacturers and importers had been granted Form-7, due to which they had created a monopoly in the market.
A statement issued by the Ministry of National Health Services (NHS) claimed that product applications were being processed on a priority basis.
“Those fulfilling the prescribed criteria are placed before the Enlistment Evaluation Committee (EEC) and if approved are granted product enlistments accordingly. Transparency International has already appreciated the working of the Drap including Health and over the counter (OTC) division,” it stated.
The ministry said that the health and OTC divisions had enlisted over 735 manufacturers and importers in a span of three years.
Published in Dawn, June 12th, 2018
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