The Case of ‘Ja’alee’ (spurious) Drugs – Where it may Go Wrong (I)- Blog Post #288 by Asrar Qureshi

Dear Colleagues!  This is Pharma Veterans Blog Post #288. Pharma Veterans shares the wealth of knowledge and wisdom of Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. If you wish to share your stories, ideas and thoughts, please email to asrar@asrarqureshi.com for publishing your contributions here.

Continued from Previous……

We have seen in adequate detail various aspects of Pharma Industry and its business; we have also seen how DRAP works to control and regulate both segments. We now take this discussion to the possible problem areas where things can go wrong.

Fake/Sub-Standard/Spurious/Counterfeit Drugs are a reflection of the malaise/weakness/rot/disease of the system. It is a problem in many countries like us as they also operate in a similar fashion. For example, it has been projected that 25% medicines in India are Fake, Spurious etc. No genuine statistics are available anywhere, including Pakistan. It does not mean the problem does not exist; it means that we do not know the extent.

I am about to complete 45 years of working and it has all been in Pharma. I cannot give you a %age, but I can say with emphasis and authenticity that fake/spurious/counterfeit drugs are not selling as a parallel business in our country. I do not count Sub-Standard in this category because no one is making wrong drugs deliberately. Yes, due to some human or technical error, a drug may not meet the laid down standards and is declared sub-standard. Sub-Standard drugs may or may not pose a health hazard. Deaths reported in US (Tylenol) and Pakistan (PIC case) were due to contamination with a wrong substance. It was a human error, and a form of being Sub-Standard, but it cost very heavily in terms of human lives.

I present following points to consider in the discussion of where things may go wrong.

1. Fake/Spurious/Counterfeit Drugs have been regularly reported, discovered and caught. In all cases, these were limited to a certain region or area. It might have gone on for a while before it was caught. The menace stopped there and later emerged elsewhere.
2. To refresh your memory: fake is when there is no drug inside; Spurious is when the contents do not match the label claim; and Counterfeit is a look-alike, it has same contents and same packaging but not original.
   1. Fake is not interesting from business point of view. It will not give any relief to patients and therefore it will not sell. Fake drugs business is not sustainable and therefore not done usually. Being no drug, a fake drug may not cause damage to patients either.
   2. Spurious may be more interesting. Putting in a cheaper drug in the packing of a costlier drug can bring more profit. For example, a cheaper antibiotic may be packed as an expensive antibiotic. Some patients may get relief, others may not, depending upon the condition. Owing to mixed response, a deliberately produced spurious drug may keep selling.
   3. Counterfeit is even more interesting. Draw an analogy from consumer market. Suppose you want to manufacture and market a shampoo; you will think your own brand and packaging and compete with 100 other brands. It is difficult business. Or you may consider making a counterfeit of Head & Shoulders with similar ingredients; it is a shampoo with almost similar benefits, but it will sell more easily and may bring more money. Same principle applies here. Counterfeits are always made for big brands. These may not be more costly per unit, but they sell a large number of units and make up big revenue.
3. Manufacturing standards have gone up and medicines cannot be manufactured by hands in the backyard of a house. It is reasonable to assume that only a proper manufacturing unit can be involved in such malpractices.
   1. DRAP system of granting licenses and registration has been improving consistently. The regulatory policing has not risen proportionately, and the effort to push older units’ upgradation is weak and listless.
   2. The Federal and Provincial Regulatory structures are disconnected. They work independently, do not share information and may even be at odds with each other.
   3. Manufacturing is regulated mainly by federal government, while retail business is overseen by provinces. The turfs are defined and are not trespassed by either party. This system was probably designed in the days of One-Unit when entire West Pakistan (now Pakistan) was One Unit. The Wahdat Colony of Lahore and One Unit Colony of Bahawalpur are a memorial of that. Things changed long ago and changed further after 18^th Amendment, but relevant changes in the structure have not been done.
   4. DCO MoH (before DRAP) was usual laid-back government department like others. DRAP concept and proposal was floated (probably by Dr. Sarfaraz Khan Niazi, a Pakistani working in the US). It kept lying and collecting dust for quite some time. No one wanted to leave the comfort zone. Finally, DRAP was formed.
   5. Like all such authorities (TDAP etc,), DRAP is a mix of old employees in the Basic Pay Scale structure, and new contract employees on new, higher pay scales. The heartburn and hostility started from the first day. The first CEO was selected after a long effort but could not accomplish much due to in-house conflicts and continuous bickering. The second CEO was appointed with some delay but is out of office due to court case. The gentleman currently working as CEO is on additional charge. A permanent CEO cannot be posted till the court case is resolved. The Directors are also working ad-hoc; their tenure is extended every three months. In this situation DRAP cannot work as effectively as it would otherwise.
   6. While the new hires at DRAP are working with new energy, the old guard is still holding on to the previous practices. Sizeable difference between the pace of working tiers causes friction and slows down the overall pace.
   7. Previous CM of Punjab came up with some new ideas which remained half-cooked. For example, DTRE lab was established in Sundar Industrial Estate, but it is still not doing much.
   8. The Summary is that the overall Regulatory Structure is not robust enough to perform its mandated jobs diligently and effectively.

Continued……