Says industry is losing out on investments due to communication gap with authorities. PHOTO: Reuters
KARACHI: Pakistan Pharmaceutical Manufacturers’ Association (PPMA) Central Chairman Dr Kaiser Waheed underlined one of the key issues plaguing the country’s pharmaceutical industry.
According to the PPMA chief, the country’s drug sector is under stress because the communication gap between the industry and the government is consistently widening.
Pharma sector believes the industry is fast losing investments because the provincial governments are trying to “overregulate it”.
“Pharma industry has some specific regulatory issues due to which there is a continuous difference of opinion between provincial governments and the industry,” Waheed said while talking to The Express Tribune.
The industry is at loggerheads with the Punjab government over Punjab Drugs (Amendment) Law-2017 and the provincial government does not seem to budge over the issue.
On the one hand, the pharma sector says overregulation is adversely affecting current investments while new players are hesitating to participate in the industry.
Meanwhile, the Punjab government believes that the state should take strict action against those who are involved in counterfeit medicines and thus the industry should cooperate with the government.
Over the last few years, analysts say, there is a growing realisation in the country that the state needs to keep up its game and properly regulate the pharmaceutical industry due to its critical role in the health sector.
PPMA officials say the problems of pharmaceutical industry in Sindh and Punjab are interlinked because medicines’ manufacturers in Sindh accounted for up to 70% drugs that are being supplied and consumed all over the country.
Pharmaceutical companies in Sindh have reservations on Punjab drugs (amendment) law because after the passage of the law, the uniform and nationwide regulatory system for manufacturing, trade, distribution, and sale of medicines in Pakistan is no more valid. Punjab has virtually adopted its own regime to control the pharma sector, which is creating problems for the industry.
After the implementation of new provincial drug amendment law in Punjab, the owners of the pharmaceutical companies in Sindh are worried because they may get harsh punishments if their medicines being supplied to Punjab are declared counterfeit or of low quality.
Drug makers say the newly passed drugs amendment law has negated the globally accepted and applicable procedure, which had to be adopted if a medicine was found to have become substandard and unfit for human consumption.
This procedure calls for immediate recall from the market of all such defective batches of drugs and in its place supply of freshly manufactured batches of same medicine.
Instead the new law calls for 10 years’ imprisonment and a fine of up to Rs100 million.
PPMA members say properly manufactured medicines could turn out to be of inferior quality due to sudden and slight variation of temperature and moisture as in such an instance contents of medicines could not meet globally acceptable pharmaceutical safety standards.
But owners of the medicines’ firms should not have to face stern punishment comprising a prolonged jail term and slapping of heavy fine.
Published in The Express Tribune, March 15th, 2017.
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