Regulator oblivious to quality cherishes cheap medicines in market

LAHORE: Drug regulatory authority in Pakistan keenly focuses on price regulation, while taking it light to ensure purity and effectiveness of medicines being supplied to market – a fact that plays havoc with the lives of patients.

As all the raw pharmaceutical raw materials are imported into the country it is absolutely essential to have a strict check on the quality of inputs being imported. Nothing should be released without proper testing or a certificate by a reputable accredited laboratory. Raw materials contaminated with injurious elements may cause more harm to the patients than cure. Pharmaceutical is a multibillion dollars trade in Pakistan and companies market only those products which are commercially feasible.

Earlier this month, the Drug Regulatory Authority of Pakistan issued a ‘Recall Alert’ to 10 local pharmaceutical manufacturing companies, advising them to recall all their medicines containing contaminated raw materials imported from China. The European Medicines Agency has already issued a warning against the Chinese raw material suppliers.

The substandard Chinese raw material is used to manufacture blood pressure control medicines in Pakistan. The local pharmaceutical companies were identified through customs documents.

In other countries, such a directive from a regulator would automatically trigger an immediate recall from hospitals, pharmacies and patients. The identified companies claimed that they had changed the raw materials and had started supplying fresh stocks to market. This is, however, a false claim as changing a raw material in pharmaceutical products requires stability testing over a period of nine months before stocks could be released for use by patients.

When a lower level or trace of a medicine subcomponent is transferred to finished products (food and medicines) it is considered harmless. But, improper manufacturing processes and monitoring can lead to its higher level in the final product, leading to toxicity damaging liver, heart and kidneys. Intake of higher level is carcinogenic.

The subcomponent is a yellow, oily liquid with a faint, characteristic odor and a sweet taste. Called nitrosodimethylamine, it is an industrial by-product or waste product of several industrial processes, such as treatment of water via chlorination for use in manufacturing various products, including processed foods and medicines. The recent detection of higher levels of such component in Chinese raw materials indicates improper processes and poor monitoring at the suppliers facility.

The drug regulator asked local pharmaceutical firms to immediately stop using of such raw materials from China. Surprisingly, even after several weeks of the alert, physical recall of the products containing the contaminated raw material is yet to be initiated and contaminated medicines are still being sold and prescribed by doctors in Pakistan.