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Continued from Previous……
In this last part, we shall see the arguments against generic prescriptions.
Here are some arguments.
Confusion about Generics and Branded Generics
There is a difference between generics and branded generics. Generics are marketed by their chemical name, such as Paracetamol, Aspirin etc. But when we talk about branded generics, these become Panadol and Loprin etc.. In many countries, generics do not carry any brand name at all. The doctor would just write the chemical name, such as omeprazole, and the pharmacist may give any omeprazole from any manufacturer. Our Drug Act currently in force requires that all pharmaceutical products shall have a brand name, be they innovator products or generic products. This act came into force in April 1976 and has just completed 45 years. During this long period, there have been some amendments but the bulk of it is still the same. DRAP asks for brand name options at the time of issuing registration letter and sometimes this becomes a hassle to find a brand name which does not resemble the hundred thousand products already registered.
If DRAP is serious about switching to generic policy, it will have to first change its own governing law. It will be a huge change which will meet with lots of resistance from stakeholders. If even after this, finally it is amended, its implementation shall need about one year to come into place. Considering this fact alone, issuing a simple memo through an additional director carries no validity at all.
DRAP Approval Process
DRAP has an elaborate set of procedures for approval of manufacturers. It starts from the approval of site at which the plant will be established, goes on to layout approval, then to inspection to grant license to manufacture. DRAP is also involved in the import of pharmaceutical raw materials. One would expect that after such thoroughness, all pharmaceutical plants would be more or less of the same standard. In practice, however, it is not so. There are wide variations in all respects. Some locations are unsuitable for having a pharmaceutical manufacturing unit, the layouts of some units do not comply with the basic requirements, the air handling and water treatment systems are poor, and the materials are a story having multiple layers.
DRAP approval process does not guarantee that the drugs manufactured by all manufacturers would carry the same quality in all parameters. During successive governments, it had been a favorite pastime to take media along, visit some medical stores and discover spurious or sub-standard drugs. There would be media hype for a day or two, and then the matter would die down. It was an entirely useless activity as it served no purpose towards improvement.
Unless DRAP cleans up its act and comes into a position of credibility to guarantee similar quality, embarking upon a generic policy will be a bad move and it would expose patients to unwarranted hazards.
Variation among Pharmaceutical Manufacturers
Pharmaceutical business is like any other business and despite regulations, anyone with enough money can start it. There are all shades of business owners with huge variation in the sense of responsibility and understanding of this particular business. It is not unlikely that usual business tactics of profiteering would be applied here as well.
Much before DRAP, the then MoH showed more lenience towards local manufacturers, in the interest of supporting the local industry. This is common throughout the world. Thanks to this policy, the local pharma in Pakistan is among the strongest local industries in the world. With the passage of time however, the local industry should have been encouraged, cajoled and regulated to bring them in conformity with the changing standards. This part was done selectively and ineffectively and currently, even the new units do not fully conform to local and international standards.
Purchases by Doctors
There is an increasing trend among general practitioners to have a pharmacy of their own directly or indirectly. This is additional source of income for them, and they try to cut deals which would yield maximum profits. It may mean buying obscure brands or else. Government has tried on few occasions to pressurize the doctors to either obtain proper licenses for their in-clinic pharmacies or stop this business. None of this initiative lasted more than three days. In this particular case, the prescription is driven by profit, not the brand or its quality thereof. The entire discussion of generic or brands become irrelevant in these cases. I would like to emphasize that this is on the increase and is already a substantial part of business for many companies.
Rise of Chain Pharmacies
Chain Pharmacies are present all over the world, and their power is determined by the market share they capture.
In KSA, chains like ‘Al-Nahdi’ are ubiquitous and Hajj/Umrah pilgrims must have seen them or might have purchased some medicine from them. Their prices are exorbitant. In 2004, while I was working in Jeddah, the news was published in the newspaper that Al Nahdi owner had applied for 1,000 new retail shop licenses. He probably got impatient and offered speed money and that was how the news broke. In Philippines, United Lab or Unilab rules the retail pharmacy market with about 90% market share. You will find a United shop on every corner. In Santiago, Chile, over 90% market is captured by three pharmacy chains.
Pakistan saw the introduction of chain pharmacies in 2000s, but it was tentative. Few branches only and no intention to grow the chain. It was also due to the fact that franchising was not in vogue and all shops had to be owned by the same owner. It became very capital intensive and prohibitive. Secondly, Lahore took the lead in this trend and other cities did not follow suit quickly. Couple of earlier chains could not sustain and went out of business. Clinix was the first chain which successfully sustained and maintained their standard. They were also among the first to offer franchise of their brand ‘Clinix’. If you buy their or any other franchise like Green, Apple, Fazal Din Pharma Plus, Guardian, Servaid, you will pay an upfront ‘Franchise Fee’ and an ongoing royalty on business. Presently, the franchise fee is in multiple of millions of rupees.
Other than chain pharmacies, several others have opted to open few outlets rather than only one. The management has become possible due to evolution of systems and software.
The rise of chain pharmacies is ominous for the patients and pharmaceutical companies. Their rise has literally killed the smaller, local pharmacies where the patients and pharmacy owner knew each other in person, and it added to responsibility. The small pharmacies could not compete with the money, glamor and variety of large pharmacy chains. All chain pharmacies are extracting extra discounts from pharma companies, a fraction of which they may pass to customers during Ramadan and so. All are selling lot of such products which have no fixed price, and which offer great room for profiteering. The ten-fold increase in the price of pulse oximeter during COVID is also this kind of work.
If generic prescription policy is implemented, it will give license-to-kill to chain pharmacies. They would stock only those products which offer maximum profit, while quality may be disregarded.
The sum up of this rather long discussion in five parts is that Pakistan is not prepared to move to generic prescription system at this time. If it is implemented forcefully, it will create chaos for the patients and will put them at great risk.
The system of generic prescription as such, is not a bad system. However, it is not universally beneficial for all countries, without regard to local conditions. It will take long, sustained preparation to come to the stage where it may be considered.
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