Regulating medical products

It is universally recognised that health is the most important ingredient of human resource development and indispensable propeller of the socio-economic progress of any country. It is considered the foremost duty of the governments to safeguard the health and safety of its citizens. To achieve this objective, stringent regulatory mechanisms are evolved to regulate the therapeutic products. These products are basically meant to treat diseases and include complementary medicines such as most dietary supplements and herbal medicines, over-the-counter medicines and prescription medicines, medical devices such as contact lenses, hearing aids, heart valves, pace makers and endoscopes, blood and blood products and cellular and tissue therapies.

The objective of these regulatory arrangements invariably is to eliminate the chances of production of substandard medicines and other therapeutic products by the unscrupulous elements within the country as well as to prevent the import of harmful medicines and equipment that can have adverse effect on the health of the citizens. The success of these regulatory regimes nonetheless depends on the effective implementation of the relevant regulatory laws and rules.

In Pakistan, the therapeutic products were regulated under Drug Act 1976 and the health ministries in the centre and the provinces were responsible to ensure its implementation. Unfortunately, the law has not produced the desired results due to a number of loopholes and its limited scope. The result is that the markets are flooded with spurious and substandard drugs and therapeutic products. It has become a thriving industry, thanks to the collaborative role of the functionaries of the drug enforcement agencies. People have even set up clandestine facilities at homes to produce spurious drugs or counterfeit of the branded drugs.

Many human lives have been lost through the use of the substandard and spurious drugs that are being marketed with impunity. The most recent example is the deaths occurring in the Punjab Institute of Cardiology which assumed scandalous proportions. The media and the people have been agitating the need for corrective measures to check the menace for a long time but the successive governments, for some inexplicable reasons, did not budge from their complacency.

In the backdrop of the foregoing, the passage of the Drug Regulatory Authority Bill 2012 by the parliament, providing legal framework for the establishment of Drug Regulatory Authority of Pakistan, is a very welcome policy initiative that indicates the concern, commitment and realisation by the present government to regulate this vital sector through a foolproof and incisive controlling mechanism to ensure that the health of the citizens is not put at risk by the unscrupulous elements.

It is for the first time that a regulatory authority has been established in Pakistan on the pattern of the drug enforcement agencies in the developed countries which shall exclusively regulate the manufacture, import, storage, distribution, sale and advertisement of therapeutic goods and also ensure effective implementation of the Drug Act 1976. The bill has been passed by the parliament after lengthy deliberations on all aspect and with due authorisation of the provincial assemblies that will ensure uniformity and harmony in regards to the implementation of the regulatory laws as well as trade and commercial practices in this area throughout the country.

The authority will have thirteen directorates dealing with different subjects from licensing to quality control and post-marketing surveillance. The act also takes care of providing legislative oversight to the traditional and alternative medicines which was a long outstanding demand of the people. A separate directorate shall exclusively deal with the enlistment, registration, evaluation and quality control of these very common medicines.

The real problem in regards to the enforcement of drug regulatory laws has been the corruption among the field staff with whose connivance and abetment the spurious drugs industry has flourished in the country. This aspect has also been effectively addressed. The accountability of the field operations has been clearly defined and the punishments and fines have been enhanced. Due attention has been given to quality control and post-market surveillance arrangements. This will not only ensure availability of quality and harmless drugs to the people but would also enhance the prospects of export of medicines produced in Pakistan.

Another very important aspect of the new legislation is that a separate directorate will be dealing with the allocation and regulation of quota of controlled substances for the manufacture of drugs, to prevent the recurrence of scandals like Ephedrine Case being heard by the Supreme Court currently. Pricing of the medicines and other therapeutic products also has been an issue of great concern.

In the absence of an effective pricing mechanism, the manufacturers have been exploiting the situation to their maximum advantage at the cost of the consumers. Some of the life saving medicines and products are beyond the reach of the common man and it is not uncommon in Pakistan to see people dying due to their inability to afford those drugs. A separate Directorate dealing with this issue, has been charged with the responsibility to interact with the manufacturers and rationalise the prices in such a manner that the interest of the patients and the manufacturers are properly safeguarded, simultaneously ensuring that the sustainability of the drug industry is not affected.

The government has taken a big stride in the right direction and it is hoped that the implementation of this policy initiative will be ensured in letter and spirit by all concerned, charged with the responsibility to make sure that the plan comes through.

Biotechnology has been recognised as a new vehicle of growth and an effort has been made to accord maximum clarity to the laws applicable to this rapidly expanding field. A policy board comprising representatives of all the provinces, FATA and experts from the private and public sector has been constituted to oversee the working of the drug regulatory authority. This indeed is an imaginative initiative for monitoring the performance of the authority in regards to the implementation of the regulatory laws and also providing policy guidelines to it on the administrative measures deemed necessary to achieve the desired objectives.