Dear Colleagues! This is Asrar Qureshi’s Blog Post #668 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 on WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here.
Continued from Previous……
Our Pace vis-à-vis the Developed Countries
The gap between our Pharma industry and that in the developed countries is increasing rapidly in recent times. We had always been slow, but the rest of the world has become faster and is gaining further speed due to huge advancements in technology.
Pharmaceutical business is regulated at all steps and the main regulator is Drug Regulatory Authority Pakistan – DRAP. Prior to this, it was Drug Control Organization – DCO under the Ministry of Health. The staff moved to DRAP when it was constituted. Inaction, delays, aversion to new developments, not recognizing where the world is going, are the hallmarks of DRAP working. There are reasons for this: poor knowledge, lack of will to learn, lack of accountability, fear of undue accountability, delaying tactics to extract favors, and the usual bureaucratic attitude are some of the reasons that plague the overall working. On top of everything else, the DRAP is overly inclined towards control of pharmaceutical industry rather than developing it. One example is that while biological drugs were gaining momentum worldwide, the biological committee of DRAP did not meet for more than a year and all applications of biological drugs registration remained pending. Similarly, the DCO took two years to decide that probiotics were not drugs and did not need registration as drug.
Some more areas requiring urgent consideration are as follows.
API Manufacturing
DRAP recently announced an API Manufacturing policy which tends to give few incentives for putting up API manufacturing units. It is a welcome step, though it is too late. A study by Gautam Arti and Kharia Anil of India says that of the 465 bulk drugs (APIs) used in India, 425 are manufactured locally. They are the second biggest supplier of APIs, after China. Pakistan pharma industry was never encouraged to develop in this area, and we have remained dependent on imports. It keeps our cost higher and becomes a hurdle when we compete for international business. Even the current policy has greater intent of control, rather than development.
Another issue with our local API manufacturing is the tariff protection. Since it is out of the scope of DRAP, therefore, the new policy does not address it. Due to this factor, the prices of locally produced APIs are quite high and the industry does not get any relief.
The developed countries stopped manufacturing regular APIs a long time ago and the job came down mainly to China and India; they went into higher technology drugs, targeted therapies, and so on. We are a large population country, and we shall keep using conventional medicines for many decades, therefore, we should encourage API manufacturing further.
Contract Manufacturing
The possibility of getting drugs manufactured from a manufacturer on contract has been a high-alert area for regulators. Considering that all drugs must be registered before manufacturing, and that all steps are regulated, this sensitivity is misplaced. Contract manufacturing is a norm in many countries, with the benefit that the manufacturing companies focus on their area and keep their manufacturing facility updated to attract more clients. The MoH, the DCO, and now DRAP are wary of allowing contract manufacturing. Even the latest policy is aimed at controlling, rather than encouraging contract manufacturing.
Contract Marketing
Contract marketing has an even more bizarre situation. Scores of smaller and larger companies, manufacturers and marketers alike, have taken products from other manufacturers and are marketing these. However, DRAP refuses to recognize this open fact and is not making any rules about it. These are therapeutic drugs, and their uncontrolled contractual business is not good for the public. Due to absence of governing policies, both business parties are also at risk. Apparently, there is no reason for this inordinate, deliberate delay. This business is already running into billions of rupees and need regularization.
Newer Fields
We need conventional medicines, and we also need vaccines, sera, blood products, and biological drugs. We are still not talking about more sophisticated drugs like gene therapies. Pakistan does not have any facility for such therapeutic agents, and we are entirely dependent on import. During 2020, not a single vial of influenza vaccine was imported in Pakistan because the three major manufacturers, GSK, Sanofi, and Abbott did not allocate any quota for Pakistan, and kept all for the US and Europe. A large number of elderly patients remained without protection for the whole year, but no one bothered. How many suffered from complications or lost lives is not known. We would not get COVID vaccine if China and Russia did not sell to us. The American and European vaccines were reserved for their own population and only the overruns were sold to us.
There is a dire need to encourage establishment of such manufacturing facilities, which we could use for ourselves and export to other countries like Pakistan.
To be Continued……
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