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Continued from Previous……
We looked at the Pharma Industry working in the previous blog. We already know that Pharma is a highly regulated business. Let us look at the regulatory structure and environment.
There are two tiers of regulatory structure; federal and provincial. The 18th Amendment created a chaos temporarily which was cleared later.
Federal organization is Drug Regulatory Authority Pakistan (DRAP) whose headquarter is located in Islamabad. DRAP has offices in all provincial capitals. Prior to the formation of DRAP, the Drug Control Organization (DCO) within the Ministry of Health (MoH) had a Director General (DG) as its head. The provincial offices are headed by Deputy Director General (DDG). DRAP at the center has replaced DG with the Chief Executive Officer (CEO); provinces still have DDGs. Under the DDG are Federal Inspectors of Drugs (FIDs). In the DCO, there used to be a Drug Controller (DC) in Islamabad. It is not there anymore; it has been replaced by the Directors. However, Assistant Drug Controllers (ADCs) are still working in provincial offices. The DDG, FIDs and ADCs represent the federal regulator, DRAP.
DRAP is responsible mainly for the Pharma manufacturing activity. It approves new units, issues licenses, grants product registrations, issues GMP certificates, conducts inspections at home and abroad, renews licenses and registrations. The FIDs regulate Pharma manufacturers at provincial level. The ADCs and FIDs also control import of related materials and export of finished Pharma products.
At the province level, there is a Director Health Services who heads the provincial health structure. The old District Health Officers (DHOs) were replaced by Executive District Officers (EDOs) during Musharraf regime. EDOs control the health units, District/Divisional Headquarters Hospitals (DHQ), Rural Health Centers (RHCs) and Basic Health Units (BHUs). The purchase of medicines and other items and equipment for hospitals is routed through this structure. The purchase process has gone through various models and is currently regulated by Public Procurement Regulatory Authority (PPRA).
There is a Chief Drug Inspector who heads the panel of inspectors located at District and Tehsil levels. The Provincial Drug Inspectors (DIs) regulate the retail pharmacy sales. Health department issues Drug Sales Licenses to Distributors, Wholesalers, and retailers. The DIs keep visiting the premises of all license holders in order to see if any irregularity is taking place.
Another activity done by Provincial DIs is to collect products from outlets randomly. In such event, the samples of the products are: 1) sent to Drug Testing Laboratory (DTL); 2) sent to the manufacturer for information and record; 3) given to the outlet for keeping as record; 4) and kept with the DI for reference. If DTL passes the product, all is well. If the test fails, the matter is referred to the Provincial Quality Control Board (PQCB). PQCB sends notices to manufacturer to appear and explain their position. PQCB reviews the entire process and may drop the case, or close the case after giving written warning, or refer the case to Islamabad with the recommendation to file criminal charges. If criminal charges are filed, the case goes to Drug Court for hearing. It could be sentencing or acquittal, depending upon the quality of handling.
I know there are many non-pharma, regular readers of my blogs, and I understand this is too much information. My apologies. The purpose is to show that a highly elaborate structure is in place to regulate manufacturing and sales of drugs.
Our highly respected satire writer, Mushtaq Ahmed Yusufi, in his book ‘Zarguzasht’ wrote about some lady. “She knew seven languages, but did not have the capability to say No in any language”
You know what I am hinting at. We do have a seven-tier regulatory structure, but it is not capable of saying No to fake/spurious drugs. One reason is corruption which runs through the arteries and veins of our entire society. How do we expect one segment of the society to act judiciously and honestly and selflessly? These guys also come from the same stock. As a society, we live, eat, drink, breathe, act and talk corruption in some way. We should have no illusion of fairness anywhere.
Other reasons, we shall take up next.