Minister sends labs on a wild goose chase after pill ‘pops’ out intact

The medication was taken for angina and high blood pressure.

KARACHI:

The poor state of drug regulation in Pakistan caught the attention of a federal minister when she noticed that a pill she had ingested came out intact in her stool.

For this to happen, right under her nose, was unacceptable since drug regulation comes under her own ministry.

A complaint was immediately sent to the relevant department. Orders were issued by the chairman of quality control, Dr Abdul Rashid, sending drug inspectors rushing to pick up samples of the medicine from Karachi and Islamabad.

The tablet is “light brown and film coated, and marked with ‘Adalat 30’ on one side” according to a copy of the test report available with The Express Tribune. It is manufactured by a German company, Bayer Healthcare AG, and is prescribed for high blood pressure and angina. It reached the Central Drug Laboratory in Karachi on June 6.

The then federal government analyst, Dr Obaid Ali, was appalled by the situation and the fuss being created.  Apparently the minister and the staff of the drug regulation department who forwarded the complaint had missed an important fact about the medicine.

The tablet is manufactured in a way that allows the active ingredient inside it, Nifedipine, to be released from a laser hole in its shell which comes out intact via the faeces. According to the drug report, “Coming out of the shell via faeces in its original shape is the beauty of formulation and does not mean that the active ingredient responsible for therapeutic effect – Nifedipine – is not released in the body.”

Dr Ali told The Express Tribune that the medicine is an innovative formulation which has been available in the market for about 10 years. “This particular situation was a prime example of the incompetence of the entire system,” he pointed out. “How else would such a small detail which was even mentioned on the tablet go undetected by the minister concerned, the chairman of quality control, the federal drug inspectors and the top tier of mangers?” Even the report mentions this fact – “The review and processing of the said complaint reveals the level of professional expertise and competence of officers who forwarded it to the laboratory.”

Similarly, Dr Ali added, that the situation of manufacturing practices in the country is so pathetic that not a single product, even those manufactured by pharmaceutical giants and multinational companies are approved in the developed world.

“This is because the manufacturing companies do not comply with the regulations,” Ali explains. The pharmaceutical industry is very knowledge-based and requires constant investment in the manufacturing facilities to maintain and upgrade the quality of drugs.

The new registration rules by the Drug Regulatory Authority require that the company must have adequate equipment, space, technical and production staff, storage, and a space of minimum 2,000 square yards. But many companies in Pakistan have been established in spaces as small as 400 or 500 square yards.

A pharmaceutical company owner, who did not want to be named, said that there were 475 licensed drug manufacturers, out of which about 50 did not follow the Good Manufacturing Practices for producing medicines.

Dr Ali believed that the government needed to improve the standard of manufacturing instead of only keeping a tab on the finished product. “This will require setting up of quality management systems, obtaining quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations and maintaining reliable testing laboratories.”

Published in The Express Tribune, July 5^th, 2012.