Drugs court rules: Warranties by wholesalers, distributors sheer violation of laws

LAHORE: Declaring warranties by unuthorised medicine wholesalers and distributors illegal and sheer violation of laws, the Lahore Division Drugs Court has directed the provincial authorities to stop this menace to prevent sale of spurious and substandard life-saving drugs.

“It is of great concern that such unlawful warranties are being produced by chemists/wholesalers/distributors which have been making the cases more challenging and harder to point out violation of the provisions of the Drug Act 1976/DRAP Act 2012”, the Lahore Division Drug court declares.

The first detailed judgement on this particular subject was passed by Lahore Division Drug Court Chairperson Azra Perveen Qureshi on Thursday with the technical assistance of two members, including Prof Dr Mubashar Ahmed Butt and Farooq Bashir Butt.

Under the prevailing illegal practice in the market, unauthorised medicine wholesalers and distributors certify that a particular drug has been registered, manufactured and marketed in compliance with all drug laws and that its use is safe.

The court also sought the assistance of stakeholders concerned before reaching a decision on this point of law, since the warranty is said to be one of the essential requirements in ensuring the delivery of quality drugs to public at large.

The court summoned and heard representatives of the Pakistan Chemists and Druggists Association and Pakistan Pharmaceutical Manufacturers Association, besides Punjab Health Services DG, senior lawyers, health managers of various districts, the Punjab Chief Drug Controller, Provincial Quality Control Board Secretary and senior pharmacists of the Health Department.

The court observed that the wholesalers and distributors were issuing medicine warranties through hand-made stamps instead by the authorized agents of the manufacturers through prescribed forms.

“The law enforcing agencies are under legal obligation to implement the law in letter and spirit but due to laxity and lack of knowledge things are getting from bad to worse”, the court observes.

“If only section 32(3) of Drug Act 1976 is implemented in its true sense, the menace of substandard and spurious drugs etc can be eliminated from the society”, the chairperson wrote in the judgement.

She asked retailers not to accept such warranties from wholesalers/distributors as these were unlawful and the acceptance of such warranties would not provide a lawful defense.

The court noted that the word “distributor” had not been defined in the Drug Act or drug sale rules and recommended that the subject of issuance of warranty by wholesalers might be settled at the level of Drug Regulatory Authority Pakistan.

“Since warranty is the basic requirement to guarantee availability of quality drugs in the country, any compromise in relation to this is likely to frustrate the very purpose of the Drug Laws” the court declared.

It declared that only the authorized agents by the manufacturers should be allowed to issue warranty.

“The provincial Government is directed to take such necessary measures for the implementation of mandatory requirements of law strictly i.e. S.32 (3), S.19(3) and S.22 (3) of the Drug Act 1976 to close such loopholes and lacunae in the system which gives benefit to miscreants and hardened criminals enabling them to escape from the ambit of law, due to illegal prevailing practices”, the court observed.

Citing many cases in this regard, the court chairperson says the real culprits of substandard and spurious drugs escape the ambit of law by providing fake and unlawful warranties.

Source: Dawn