Daily Times

As per a report issued by the World Bank, in Pakistan spending on education, health and nutrition is only 3 percent of the GDP which is significantly lower than other countries. Moreover, in Pakistan only 0.5 percent to 0.8 percent of the GDP is being spent on health, since the last decade, whereas the standard set by World Health Organization is at 6 percent of the GDP for any country. This is the minimum contribution required to provide basic as well as lifesaving health services.

On July 12, 2018, the Drug Regulatory Authority of Pakistan issued a ‘Recall Alert’ to 10 pharmaceutical manufacturing companies advising them to recall their Valsartan medicines which contained a contaminated raw material imported from China.

Valsartan is a molecule, an active ingredient used in the composition of medicines for hypertension which aids in preventing cardiac arrest. It is important to make it clear that not all Valsartan is compromised but in fact, just a batch of raw materials contaminated with a cancer causing impurity. Therefore, the problem does not lie with the high blood pressure molecule but in fact in the contaminated raw material used in its manufacturing. The N-Nitroso, a carcinogenic impurity which can lead to cancer from the continuous use of the Valsartan obtained from this compromised source.

NDMA or Nitrosodimethylamine also known as dimethylnitrosamine (DMN) is a thick yellow liquid with oily texture and a particular smell and taste. It is an industrial by-product and is used for several industrial processes, such as in manufacturing various products including processed foods and medicines. While lower levels or traces of NDMA can be transferred to finished products (food and medicines), these would still be considered harmless. However, improper manufacturing processes and monitoring can lead to higher levels of NDMA in the final product which can result in increasing the toxicity and damage the liver, heart and kidneys. Moreover, an intake of higher levels of NDMA can prove to be carcinogenic to humans.

Valsartan is a molecule, an active ingredient used in the composition of medicines for hypertension which aids in preventing cardiac arrest. It is important to make it clear that not all Valsartan is compromised but in fact, just a batch of raw materials contaminated with a cancer causing impurity

Patients who are unaware of how they should go about it should refer to ‘Safe to Use’ list issued by DRAP and the Punjab Drug Control Unit. However, due to the lack of awareness among the general public, pharmacists took it upon themselves to guide patients on which medicines should be consumed as an alternative.

The contaminated imported raw material is still being used to manufacture blood pressure medicines in Pakistan. The local pharmaceutical companies were identified by using documents submitted by these companies to the Customs authorities, seeking permission to clear the contaminated raw material stocks.

In other countries, such a directive from the regulator would automatically trigger an immediate patient level recall of the contaminated medicines from hospitals, pharmacies and patients but not in Pakistan. In our country, it is unfortunate that the writ of the government has completely eroded and the identified pharma companies instead of initiating an immediate recall to protect the lives of patients, have started a campaign to safeguard their vested commercial interests. It is disappointing to note that the same companies are being protected by officials of the regulatory authorities and are being supported by sections of the medical community.

The identified companies claimed that they have initiated a ‘voluntary recall’ in the best interests of the patients, completely ignoring the fact that they have been mandated by the regulator to recall products which contain the contaminated raw material.

Not long after that, the identified companies claimed that they have changed the raw material and have started supplying fresh stocks. It is important to highlight that changing a raw material in pharmaceutical products requires stability testing over a period of nine months before stocks can be released for the patients usage. But within a month the listed companies bombarded the public with messages claiming that they are free of contamination and fit for use.

DRAP’s proactive intervention and public alert is much appreciated, however such a serious health risk and country wide recall of the widely used molecule (Valsartan) somehow proves that there is a lack of check and balance regarding raw materials being used in the manufacturing of medicines in Pakistan. Such lax rules allow imitators to enter a sensitive industry and play with the lives of the patients. Criminal acts like this can only be possible in Pakistan where the writ of the regulator seems to have completely disappeared, leaving the unsuspecting patients at the mercy of mass murderers.

Now it is the responsibility of the new government and the policymakers to take notice of the issues faced by the general public, especially problems in the health sector. It would commendable if the new government can tackle issues related to the health sector such as hygiene, non-communicable diseases (NCDs), the use of spurious drugs and the affordability of medicines.

The writer is a communications practitioner and can be reached at: kfnaim24@gmail.com

Published in Daily Times, September 30^th 2018.