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Pharma Industry in Pakistan is going through difficult times, and it is not just due to Pak rupee devaluation or rising cost of production. There are several pain points, some gathered internally over time, and some brought on by government policies and circumstances.
Let us talk about three major pain points. I may add here that pharma industry also has a role in getting pain inflicted on it.
Without doubt, it is the biggest pain point. And the main responsibility lies with the decision makers in the government because successive governments have deliberately avoided to make a proper pricing policy. Few years ago, when they were coaxed by the Honorable Sindh High Court persistently, DRAP finally came up with a policy which they later did not implement in its true spirit.
While essential commodities’ and utilities’ prices keep rising unchecked, no one makes it a political issue. Government has increased electricity and gas prices beyond any reason, but the treasury and opposition stand together in the pursuit for oppressing common people as long as their own interests are safeguarded. Though it is a matter of public interest, but judiciary shall neither take notice nor provide relief, if approached. Few years back, Shahbaz Sharif, then Chief Minister Punjab slapped a one-time special property tax of 500,000 rupees on all houses in Lahore measuring two kanals or more. It was without any justification or merit. Some of the aggrieved went to Lahore High Court which did not give relief.
Essential commodities, education, and utilities make up over 95% of a household expenses. For the same reason, even education is ignored when it just does not fit into the budget. Medicines are less than 1% of expense in most households unless there is serious sickness.
The point is that why medicine prices are so big an issue? It is just a ploy to show that the government cares about people and is keeping the drug prices under control.
Pakistan Pharmaceutical Manufacturers Association – PPMA is inherently weak due to its own conflicting stances, internal weaknesses, and wavering behavior. It has not been able to put up a strong case to the government on any issue.
So, the pain continues. The industry keeps cribbing but cannot do much. The government does not want to disturb the status quo.
The second big area of pain is the regulators, not the regulations. The regulations are not designed by DRAP, these are shared by other health authorities who are ahead of us and are copied here with or without small tweaks. The world has been moving very fast and new regulations are introduced as new information on the use, misuse, and adverse events is surfaced. Same holds true for new issues encountered in production, quality control, and storage of drugs and drug components.
The problem with many regulators is that they are not well-versed with the latest knowledge and so they go by the old information they had twenty-thirty years ago. The WHO, and USP had been conducting workshops to update regulators, but the uptake and retention is highly variable.
The attitude of regulators is another major area of pain. It is customary for the regulators to use derogatory language with the staff and even with the owners.
Pharma companies are also responsible for bad behavior of regulators because they do not comply with the regulations fully and then try to make it up with other measures. Respect is lost in this process. There are plenty of manufacturing plants which barely qualify for manufacturing parameters. Ministry of Health previously, and DRAP even now show leniency towards such manufacturers to let them stay in business. They give advisory and warning for improvement which is not heeded to.
Drug Regulatory Authority Pakistan – DRAP is the chief regulator of pharma industry in Pakistan. Upon the formation of authority, most staff were inducted from the ministry of health departments, while some new staff including the CEO had to be hired from outside. Several posts of directors and deputy directors and assistant directors were included in the organization chart, some were advertised, and applicants interviewed, but then the process got mired into departmental infighting and legal battles. The first CEO was inducted after three years, met stiff resistance from existing staff, and could not accomplish much. The second CEO was from the staff, but he was later removed unceremoniously. After a gap, the present CEO was upgraded from internal applicants. Just a few days ago, DAWN news published a news item saying that he had been show-caused by the parent ministry, Ministry of National Health Regulations and Coordination.
DRAP working is getting delayed with time while cases are piling up. There are too few people to handle too many cases and they just cannot do it. The amassing of power in few seniors’ hands is a further cause of delayed processing and decision making.
DRAP has also raised existing fees by many times and introduced new fees which are just a sham. The intent to generate money is open and naked.
DRAP does not facilitate in complying with its own regulations. For example, a generic manufacturer needs to do Comparative Dissolution Profile – CDP with the original brand imported from Europe or US, if it wants to apply for registration of the generic of a newer molecule. However, DRAP plainly refuses to provide support for importing the brand pack; they would not even issue a note for Customs. This is anomalous, to say the least.
There are several other pain points of varying intensity. The sum up is that there is no effort at the government or agency level to upgrade the pharma industry in Pakistan, and to enable it to compete with other countries; in fact, there are counter efforts to stall the progress of the industry.
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