Financial non-viability wiping lifesaver drugs off shelves

LAHORE: Local and multinational pharmaceutical industry is facing difficulties in getting new drugs and their prices approved, and also being threatened with higher penalties, unheard of even in the western world.

There are no two opinions that the state has the responsibility to ensure availability of best quality medicines to its citizen at affordable rates. Drug regulatory authorities operate in almost all countries to eliminate spurious and substandard drugs and fix prices to ensure that medicines are available at lowest possible rates for the patients, while drug manufacturers get judicious returns on their investment.

Drug Regulatory Authority of Pakistan (DRAP) is performing the same function. The non-availability of many essential and life saving drugs in Pakistan raises many questions about the regulator.

As of today, some essential drugs needed in the treatment of heart disease and heart stroke are not available in the market. These include angised tablets, lenoxin and lenoxin injection.

Similarly, TB drugs, including Myrin, Myrin P, Myrin forte P, ethambutal, are missing in the market. Among the vaccines, flaurix injection, Veroreb, snake venomen ergix-B and pneumo23 are also not available.

Life saving drug thyroxin is sporadically available; salbo inhaler needed in allergies is also not on the shelves of drug stores. The list goes on.

The drugs are missing from the market because of price issues. Neither the multinationals nor the domestic manufactures are producing these drugs or their alternatives because of economic non-viability.

Recently, the Punjab government announced harsh punishments for both substandard and spurious medicines. Here whims instead of minds were applied, which resulted in province-wise protests by all stakeholders.

According to the experts, substandard drugs are those when the quantity, colour or the coating on the tablet is damaged. This could be possible due to human error. The worldwide practice is that in such cases the entire batch is lifted from all outlets.

Another reason of substandard drugs could be the storage conditions. Mostly drugs are to be stored at 20-30 degree centigrade, and some drugs are stored at 0-8 degree centigrade.

Most of the pharmacies in Pakistan are not air conditioned and drugs on the shelves are exposed to direct sunlight. In summers, the temperature is too high which deteriorates the strength of drugs and they become substandard.

For drugs to be kept at low temperatures, pharmacies do keep deep freezers. However there is no backup in case of load shedding. Before taking action against the drug manufacturers, Punjab government would have to ensure that all registered drug stores maintain the ideal temperature required for drug storage on their premises.

The prison term for making and marketing spurious drugs should be more severe because these drugs do not contain the active ingredient in their formulation. Moreover, these are produced illegally by unlicensed manufacturers.

Another serious issue in drug regulation is related to biological products. The DRAP is bound as per schedule 1 of DRAP Act 2012 to approve such drugs on guidelines provided by World Health Organisation (WHO).

There are three types of biological drugs. The first is the reference bio-therapeutic product (RBP). This type is produced by a company following clinical trials on animals and later on humans.

The beneficial and side effects of the drug are scientifically documented as required by WHO. Then there is bio-similar product (BSP) that is similar to RBP and has undergone all clinical trials as per WHO requirements, which shows it is similar in quality, safety and efficacy to an already licensed RBP.

Another set of biological products are available in the market that claim to have the same quality, safety and efficacy as that of RBP and BSP but the manufacturers have not conducted clinical trials to show the beneficial and side effects of the bio-therapeutic drug. 

Experts call these drugs as non comparable bio-therapeutic drugs. The DRAP act forbids approving these drugs, as they did not follow WHO procedures. Still some NCBs were given approval in Pakistan, which have been challenged in the courts.

It is interesting to note that while NCBs were accorded prompt approval, a cancer cure drug named Applead is awaiting government approval since 2013. It eliminates breast cancer if it is diagnosed at an early stage.