Ministry approves import of active pharma ingredients from India

LAHORE: The Ministry of National Health Services, Regulations and Coordination has approved resumption of import of active pharmaceutical ingredients (APIs) from India for manufacturing of essential medicines.

“Some people are confused about therapeutic class and essential lifesaving medicines and they create hypes,” said Dr Zafar Mirza while chairing a meeting with a delegation of Pakistan Pharmaceutical Manufacturers Association (PPMA) at the ministry’s committee room on Friday.

The meeting was attended by Secretary NHSR&C Amir Khwaja, Chief Executive Officer (CEO) Drug Regulatory Authority (DRAP) Asim Rauf, PPMA leader Asad Shujaur Rehman, Advisor to Governor Punjab and Member CEC PPMA Ansar Farooq Chaudhry and others.

According to the meeting minutes available with The News, Dr Zafar Mirza advised DRAP chief executive officer to continue routine approval (of APIs from India) without any stoppage. Asad Shujaur Rehman raised a point that Assistant Drug Controllers (ADCs) of DRAP regional offices were not approving the import of APIs from India, which would lead to severe shortages of essential medicines in the country.

“There are no such instructions to the ADCs,” Dr Mirza said. He said that once investigation ends, he would explain the facts to the public during a press conference.

He also advised DRAP CEO to separate summaries of hardship cases and new molecules. “Summary regarding price fixation for new molecule shall be placed in the next second cabinet meeting for approval,” he added.

The state minister said that there was no ban on export of pharmaceutical products. He said that earlier a Statutory Regulatory Order (SRO) was mistakenly issued, imposing a ban on all therapeutic class, while it actually belonged to anti-malarial, rather individual ban on molecules related to Covid-19 like hydroxychloroquine and chloroquine. He advised the DRAP CEO to change the SRO accordingly immediately. He said that companies were allowed to export these molecules based on import of raw material quantity e.g. if 500kg raw material had been imported, then same amount of finished product could be exported.

The state minister said that export of sanitizers had already been permitted. He also suggested discussion for preparation of framework for good manufacturing practices (GMP) fee and then a discussion with the Ministry of Commerce on export-related matters.

On PPMA’s demand to add pharmaceutical industry to five export sectors, Dr Zafar Mirza assured that it would be done. Since it falls in the domain of the Ministry of Commerce and NHS, he asked the PPMA to send a plea in writing on Monday. He advised the PPMA to donate to the PM’s Fund for Covid-19 as a goodwill gesture. It will make our viewpoint more precise for adding pharmaceutical industry to five top export sectors.

On the PPMA demand that sales tax/duties might be adjusted in tariff rationalisation, the minister promised that it would be done before new financial year. DRAP CEO Asim Rauf did not respond to frequent calls for his version in this regard.