Dear Colleagues! This is Asrar Qureshi’s Blog Post #643 for Pharma Veterans. Pharma Veterans welcome sharing of knowledge and wisdom by Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi onWordPress, the top blog site. Please email to firstname.lastname@example.org for publishing your contributions here.
February 2022 marked my completing 47 years of working in Pharma Industry. Allah be praised. I am still working. My journey of near half century is also the journey of Pharma Industry in Pakistan. Great changes have occurred in this time and a lot could be written about it. In my blogs, which were started about four and a half years ago, I have covered several topics related to Pakistan Pharma Industry. This multi-part series is the SWOT – Strengths, Weaknesses, Opportunities, Threats – Analysis of the Pharma Industry and propose strategies.
EPILOGUE … II
Local Pharma industry has many great things about it as mentioned in the last post. It also has plenty of issues which we shall discuss here.
- The progress of Local Pharma companies is highly uneven. It cannot be the same anywhere in the world but in our case, different tiers of companies are living in different ages. The technical expertise, equipment, processes, procedures, and practices of lower tier companies are old and redundant. They are living in the previous age and surviving thanks to courtesy of DRAP. This serious contrast has many implications.
- Even more serious is the fact, that the lower tier companies are not even making effort to improve. They believe they can carry on business in this way indefinitely. The regulations are flouted and some of them are seriously involved in malpractices.
- The biggest issue with this disparity is that the quality of drug which reaches the patients is variable, may be highly variable in some cases. This is unfair to the patient because he is paying for the right drug. In chronic diseases, the management depends upon the quality of drug. If it is not right, or is variable, the control of diseases like diabetes and hypertension will be disturbed. In acute conditions such as infections, the eradication of infection may not be achieved. The talk about development of resistance due to sub-optimal dosing is the later issue.
- Local Pharma does not have effective representation at the government and public level. The only representative arm of the local industry – PPMA – Pakistan Pharmaceutical Manufacturers Association is always divided between diverse demands from its members. The upper tier has completely different concerns as compared to the lower tier companies. While the upper tier is focused on development, the lower tier is focused on protecting its traditional practices. The two cannot be reconciled and therefore upper tier members do not work with PPMA, and it is dominated by the lower tier companies. PPMA has lost its effectiveness and authenticity due to this factor and is unable to achieve anything worthwhile.
- The entrepreneur in Local Pharma is interested in maximizing his profit and draining upon the resources of enterprise to invest elsewhere. There is no reinvestment. Pharmaceutical industry is among those where the pace of regulatory changes is fast. As soon as new need is uncovered, a new regulation is put in place. Most of these relate to documentation, and some to technological improvement. The latter may require investment in equipment, while the former needs investment on people training, and/or inducting new, qualified people. This is rarely happening or not happening at all.
- DRAP has no justification for giving relaxation to old plants for not coming up to current standards. The mandate of DRAP is to formulate and implement regulations uniformly; not applying these selectively. In a way, DRAP is failing in its obligation towards public. Personal relations, connections and services rendered to officials by the entrepreneurs are scandalous and must be severely discouraged.
- Pricing is probably ‘the most objected to’ procedure at DRAP. Actually, pricing is not in the domain of DRAP; it is still under the parent ministry. Why this anomaly is continuing is baffling but continuing. The pricing section has developed some complex mechanism to award prices for new molecules and new registrations of old molecules. They take prices from India, Bangladesh, Iran etc. for generic products and add US/Europe for new research molecules applied by the MNCs. It is interesting to note that the MNCs always end up getting good prices while Local Pharma keeps crying about prices. This system is flawed. The basket for generic pricing does not show which tier of companies it represents. Secondly, India produces it own basic materials which are available to local manufacturers at lower prices. Thirdly, the wages and tariffs of utilities are not comparable. This makes the basket prices concept inherently incorrect.
- Three years back, the government announced that the Pharma companies could increase the prices every year in relation to the CPI – Consumer Price Index based inflation percentage announced by the government. It happened smoothly during the first year and was probably not liked by the pricing people. So, they raised some barriers during second year. In the third year, they stopped the automatic process altogether. They said the companies would submit the revised prices, these would be reviewed, and a written approval would be given to implement increase. In addition, they asked for a fee for each SKU – Stock Keeping Unit of the products. The cost runs into millions which DRAP in connivance with Pricing has slapped on the industry without justification.
- Local Pharma is severely handicapped in research and development, and this handicap is partly due to financial and partly due to personal reasons. The public does not know that DRAP collects 0.1% of turnover under the head of CRF – Clinical Research Fund. During the last so many years, DRAP, and the MoH before it, collected money which would be in billions by now. They are still collecting it forcefully. However, they have never conducted any clinical trials, have not invested on establishing a facility for research or supporting the companies who do such research. The whereabouts of that money and its fate are shrouded in mystery.
These are some worries the industry is facing. There may be more also. The biggest issue is that the grievance handling is poor, high-handed, and inefficient and therefore the regulator and the industry do not work together for improvement.
To be Continued……
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