ISLAMABAD: A bill to increase punishments for companies who manufacture substandard drugs has been referred to the National Assembly standing committee for further deliberation, despite strong opposition from National Health Services (NHS) Minister Saira Afzal Tarar.

Titled ‘The Drug Regulatory Authority of Pakistan (Amendment) Act 2016’, the bill was tabled by nine MNAs from MQM. The bill demands that punishments and fines for those involved in manufacturing substandard drugs should be increased, and the crime should be made a non-bailable offence.

According to the draft available with Dawn, despite the prohibition, offences and punishments included in the Drug Regulatory Authority of Pakistan (Drap) Act 2012, criminal activity in drug manufacturing, sales and import and exports has increased manifold. The draft says the main reason for this is the lax punishment enshrined in the 2012 act.


Proposed law calls for increased punishments for substandard drug manufacturers


It also states that complaints have been levelled against drug inspectors for inefficient and connivance with drug manufactures which need to be addressed, and proposes that punishments be introduced in this regard.

One of the movers of the bill, MNA Sufyan Yousuf, told Dawn there is no trend for research in Pakistan, so most medication formulas are invested in other countries, where they are patented.

“In Pakistan, a trend has begun where companies select an international formula, change the quantity of ingredients in the formula and manufacture the medication under another name,” he said.

“Heart and liver patients have been suffering because of substandard drugs [that lack ingredients in the right quantity]. Let’s suppose a heart patient needs a fixed dose of medication to reduce cholesterol in the blood. Substandard medicines decrease cholesterol, but they increase blood thickness at the same time because another ingredient is in lesser quantity,” he added.

Mr Yousuf added: “In the Code of Criminal Procedure (CrPC), there is a standard of three to seven years imprisonment, but in the Drap Act there is only six months imprisonment and a Rs50,000 to Rs100,000 fine. Because of this, companies continue making substandard drugs.”

“We want that there should be four to 10 years imprisonment and Rs10 million fine for manufacturing substandard drugs,” Mr Yousuf said. “We only have two MQM members in the standing committee on NHS but we will try to build a consensus to pass the bill.”

Speaking on the National Assembly floor earlier, Ms Tarar said instead of referring the bill to the standing committee, members should discuss the matter with Drap.

She suggested that punishments are not being levied on violators, and that existing punishments should be ensured rather than increasing punishments. “It is a technical matter, so [it] can be addressed through a notification,” she added. She added that drug inspectors are already scared, and have been facing Federal Investigation Agency cases, so they should not be frightened further.

“Registered companies do not make spurious drugs so they should not be treated as if they are making fake medicines. If some ingredients in the medicines are increased or decreased mistakenly it does not mean that the drug should be treated as spurious,” she added.

Published in Dawn, April 15th, 2016

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