The Health and OTC Division – an unnecessary burden on the exchequer?

By Ahmad Fakir Muhammad

The Health and OTC Division (HOD) of the Drug Regulatory Authority of Pakistan (DRAP) was set up in 2014 to evaluate, register and regulate alternative medicinal products (AMPs) so as to ensure their quality. Alternative medicine, apart from other therapies, includes homoeopathy and Tibb.

Five years into its existence, the HOD has not made any remarkable progress in the matter. The manufacturers and importers who have to deal with it complain of sloppy work, lethargic attitude and mismanagement and consider it to be an unnecessary burden on the national exchequer. According to them, tens of thousands of dossiers for registration of AMPs have piled up in the HOD depository, awaiting evaluation. The number of dossiers evaluated and approved during the past five years is dismally low – hardly 7 to 8% of the total number of products in alternative medicine. At the current pace, the HOD will take more than 55 years to register the existing AMPs alone!

There are many reasons for the huge backlog of dossiers. First, the officers concerned do not follow the stated policy of the DRAP. According to the announced policy, the AMPs included in the pharmacopoeias adopted vide Alternative Medicines and Health Products (Enlistment) Rules, 2014 are exempt from detailed scrutiny and are to be registered on the provision of a registration certificate issued by the health authority concerned of the country of origin. But in practice, the officials concerned do not adhere to the stated policy.

Secondly, there is a lack of knowledge and technical know-how among the HOD staff about the subject they are supposed to deal with. Ideally, the persons responsible for vetting the dossiers should have a thorough knowledge of the subject as the processes involved in the manufacture of AMPs, particularly homoeopathic products, are quite different. In its technical document on the subject, the WHO recommends that the tests to evaluate homeopathic products should be adapted to the particular requirements and special characteristics of homoeopathic manufacturing process. The DRAP has not been able to set up a specialized laboratory as per the WHO recommendation to properly evaluate homoeopathic products.

Thirdly, there is no working manual for the officers concerned to follow while vetting a dossier. This has given them a free hand to approve or disapprove a dossier according to their whims. They can approve a dossier with deficient documents and they can raise frivolous objections on a dossier fully meeting the requirements. The fact that the products of some dubious companies have been registered while the dossiers of the products of some well-reputed companies have been left to gather dust in the HOD depository points to arbitrary use of discretionary powers enjoyed by the officers in the absence of a working manual.

Fourthly, the minutes of the meetings of the Enlistment Evaluation Committee (EEC), held every month to evaluate dossiers for registration of products, are not made public. The last minutes available on the website of the DRAP are of the 16th meeting of the EEC held as back as in November 2016. Since, then, what has been happening at the EEC meetings is not known. Even on demand, the minutes are not provided to the applicants. Withholding information falling within the public domain cannot be justified under any circumstances as that violates Article 19-A of the Constitution of Pakistan which guarantees peoples’ right to access to information held by public bodies.

What is intriguing is the publication of notices by the DRAP on a regular basis in the leading newspapers warning the public against sale/purchase of unregistered AMPs, terming the activity as illegal. What is the point in issuing public notices when thousands of applications have been pending with the HOD without being dealt with for years?

Clearly, the HOD’s performance has been totally unsatisfactory over the past five years. There is a need to restructure and reform it. Failure to do so would defeat the purpose for which it has been brought into existence and would only serve to reinforce the impression that it is an unnecessary burden on the national exchequer.

The government would do well to restructure and reform the Health and OTC Division so as to make it effective and capable of serving the purpose as envisaged in S.R.O. 412 (I)/2014.