ISLAMABAD: The registration board of the Drug Regulatory Authority of Pakistan (Drap) has approved new rules for the registration of medicine to ensure their quality, stability and efficacy.
Now, not only will pharmaceutical companies be able to register medicines after a laboratory scale feasibility study, they will have to submit a drug stability study after producing three commercial batches.
However, companies who only want to export medicine can do so without submitting a stability study.
Drap Chief Executive Officer Dr Mohammad Aslam told Dawn that the decision was taken to avoid the illegal import of chemicals and the sale of unregistered drugs.
“In the past, a number of companies used to import different drug molecules, worth millions of rupees, without registration. If their medicine was not registered, they were then forced to sell them, without approval, to avoid losses amounting to millions of rupees,” he said.
Drap makes it mandatory for pharma companies to submit lab, stability studies
He said that at the 249th meeting of the registration board, held on May 18 and 19, it was felt that the procedure for stability studies was not up to the mark and there was a need to bring it in sync with the guidelines of the International Conference on Harmonisation of Technical Requirement for Registration of Pharmaceuticals – or ICH for short – and the World Health Organisation (WHO).
“It was decided that all drug manufacturers will obtain registration after submitting a laboratory study to get permission to import small molecules for their medicine. However, after three commercial batches or two pilot batches (20 per cent of the commercial batch) and one commercial batch, they must submit a drug stability study,” he said.
A drug stability study measures how long a drug will remain effective and what its shelf life is. These are conducted to ensure that medicine that is stored for a long time remains effective.
Dr Aslam said under Drap rules, only a small quantity of drug molecules could be imported for laboratory tests. Nearly all drugs are made of small, chemically manufactured molecules, which can be replicated to make any drug.
“Drug manufacturers would adopt illegal ways to import molecules because they had to submit stability reports without registration. Now, they will have to first register the medicine and will submit their stability report,” he said. It was also decided that Pakistan Pharmaceutical Manufacturing Association (PPMA) will take part in the process of stability studies.
However, independent drug manufacturing consultant Nadeem Hussain Alamgir told Dawn that according to ICH standards, a company may conduct both the laboratory and stability study itself.
It has also been decided that companies that want to manufacture medicine for hepatitis will get special treatment because of the huge number of hepatitis patients in the country, he said.
“After that company submits the study and Drap reviews it, in case the study report has been faked or the medicine expires while on the shelves, the company can be blacklisted,” he said.
Dr Aslam also said that companies who wanted to export medicine would be allowed to do so without the stability study, because it would be the responsibility of the importing countries to ensure the quality of the drugs.
“This decision was made to increase the exports of medicines. However, companies must have complete technical documents to get themselves registered for export,” he said.
The policy can be reviewed in case of a complaint by any foreign country, he said.
An official statement issued by the Ministry of National Health Services said that some applicants had recently submitted their stability data, which was also placed before the board.
The board discussed the data but found that it did not fulfil the minimum requirements to establish the quality, safety and efficacy of applied drug product, therefore the board decided to develop further guidelines for local manufacturers for conducting appropriate stability studies.
Published in Dawn, May 26th, 2015