Dear Colleagues! This is Asrar Qureshi’s Blog Post #866 for Pharma Veterans. Pharma Veteransaims to share knowledge and wisdom from Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to firstname.lastname@example.org for publishing your contributions here.
This blogpost partakes from a June 2022 article by Shahid Mehmood of PIDE, published in Munich Personal RePEc Archive. Link at the end.
DRAP – Drug Regulatory Authority Pakistan is the regulatory body for regulating the pharma industry, and it is not always straightforward to analyze the performance of a regulator. Indirectly, the status and performance of pharma industry in any country reflects the performance of its regulator. It is also true that the industry and regulator have a love-hate relationship; they detest one another but cannot live without one another.
The most referred to regulator is USFDA. They are considered to have elaborate and stringent frameworks for regulating the industry, but even FDA has changed its policies a lot over time. It is not strange because industry and regulator must work together to ensure that the rules are followed, and the industry interests are also safeguarded.
The role of regulator is not just policing; it is also to develop and steer the industry as per need of the population. Historically, entire regulatory structure in Pakistan has been oriented towards exercising authority, and not adding value.
DRAP was founded in 2012, and pharma industry regulation was transferred from DCO – Drug Control Organization within Ministry of Health to DRAP.
The reference article evaluated the performance of DRAP across five main themes. It is a long document, but I shall extract relevant summarized information to put it here. To keep it crisp, I shall take two parameters here, and others later as separate posts.
Quality of Drugs and Drug Dispensing
Two mechanisms are presently in place for these parameters.
For quality of manufactured drugs, DRAP has field offices, and their inspectors visit the distributors/wholesale/retail pharmacies, and the manufacturing units. They collect random samples and send these to government laboratories for quality testing. If the sample fails, then another mechanism is triggered which may take the concerned person(s) to drug courts where prosecution may take place. The issues with this system are that it can only check after the drug comes in the market and that also if at all it is checked. There are over 100,000 drugs on the market, and billions of units are sold, catching the ones with low quality is an effort which is not likely to bear much fruit. Quality of drugs is an old issue and keeps surfacing here and there. In 1975, the Generic Drugs Act was repealed after 38 companies were found to be producing sub-standard drugs. It was replaced by the Drugs Act 1976. In 2011, over 230 people were killed by the adulterated cardiac drug. The reaction led to expediting the formation of DRAP, whose proposal had been around for several years, and on which the Ministry of Health was not acting. It was followed by the contaminated cough syrup case which took some more lives. The point is that quality of drugs must be improved at the manufacturing units, for which more frequent and stringent inspections are required. Licensing and license renewal also needs better handling because several manufacturing units are in shambles.
Quality of dispensing is at the pharmacy level. There has been improvement at least in the major cities, but much more is needed. The mandatory availability of a qualified pharmacist is not practiced, except a tiny few pharmacies. The owners or staff running the pharmacy are not much educated, but they still recommend substitutions. In suburban and rural areas, dispensing of drugs by quacks/ pharmacy owners is rampant. Another important issue is that almost all drugs can be purchased without a prescription. It makes life easy but is not the right practice. Drug inspectors who are assigned to pharmacy checking are complacent and complicit, thereby leading to unabated continuation of malpractices.
DRAP has increased the effort in this area, some manufacturing licenses have been suspended, several drugs were declared substandard, and their sales stopped, and some convictions also took place. However, the size of the task is huge, and DRAP is neither equipped nor fully willing to come hard in these areas.
Government structure for testing of drugs is run through DTL – Drug Testing Labs, of which 12 are available across the country. In Karachi, there is a CDL – Central Drug Laboratory. All batches of drugs supplied to public sector hospitals are referred to DTLs for testing before acceptance, which keeps them quite occupied and time for other testing is not available.
Consistency of Policies
The pharma industry has been at the receiving end of policies made by bureaucrats and ‘experts’, which are frequently amended also. The famous (or notorious) instrument is SRO – Statutory Regulatory Order, which are issued every so often for amending, adding, deleting, portions of existing policies.
Numerous examples can be cited of conflicting SROs.
- SRO, No. 113(I)/2021, dated 2nd February 2021 was issued by DRAP, allowing unfettered, unrestricted import of vaccines from abroad, allowing the importer to sell it as per the market price. However, on 18th March 2021, another SRO (No. 308(I)/2021) rescinded the previous SRO, leaving the population without a shot at more vaccines.
- SRO No. 307 (I)/2021, dated 18th March 2021, regarding COVID-19 vaccines. SRO stipulates that the vaccine shall be first approved by DRAP. Recently, however, new vaccines landed in Pakistan (bought by the federal government) without DRAP even knowing anything about it.
- Four SROs were issued between 6th and 17th April 2020, all cancelled by SRO (F. NO 4-2/2017-DD (H&OTC) in lieu of Cabinet’s decision on 5th May 2020
This is just a snapshot; there are several more instances like this. Apart from consistency, DRAP almost always works reactively, rather than proactively. This may be another factors causing inconsistency. The cases of low-osmolarity ORS, registration of Fludrocortisone tablets for congenital adrenal hyperplasia, directions to declare gluten/lactose content are some examples of reactive decision making.
DRAP and other such authorities do not entirely fit the definition of a ‘public authority’. The authority is established to make the organization focused, lean, agile, highly professional, and working on merit. In Pakistan, the public authorities are dominated by bureaucrats who do not understand the technical nuances; the same is happening in DRAP. Rather than strengthening the institution, successive health secretaries tend to keep it under their thumb. The staffing had been inadequate for long, and still is in relation to the workload. Positions are occupied by adhoc staff who get extension for three months, every three months. The Policy Board is not as functional as it should be. in fact, it has acted only to raise the fees. And on top of everything else, there is constant internal strife.
DRAP is an improvement over its predecessor, DCO, but it is not the kind of knowledgeable, updated, proactive, quality-conscious, certified to be authentic, and strong to lead the desired changes in the pharmaceutical landscape. DRAP must be liberated and strengthened to do what it must be doing.
Disclaimer: Most pictures in these blogs are taken from Google Images and Pexels. Credit is given where known; some do not show copyright ownership. However, if a claim is lodged at any stage, we shall either mention the ownership clearly, or remove the picture with suitable regrets.