SHC dismisses petitions against amendments to drug regulations

The Sindh High Court (SHC) on Tuesday dismissed the petitions against certain drug regulations’ amendments about selling and stocking drugs, saying that by regulating drugs’ sale and stocking, a system of checks and balances has been put in place to safeguard the interests of underprivileged patients.

The Pakistan Pharmaceutical Manufacturers’ Association and others had challenged the provincial government’s notifications about the amended drug rules. They said that through the impugned notifications, the government has restricted the sale of drugs and controlled substances, claiming that such amendments are contrary to the provisions of the main statute, the Drugs Act, 1976, which falls under the ambit of the Control of Narcotic Substances Act, 1997.

They added that the impugned amendments and rules are against the main statute, and that these amendments would create obstacles in running their businesses, so the petitioners’ members would not be able to manufacture the drugs made from controlled substances.

After hearing the arguments, and the perusal of the notifications and the relevant laws, an SHC division bench headed by Chief Justice Mohammad Shafi Siddiqui said the petitioners are pharmaceutical manufacturers’, chemists’ and drugs’ associations. The court said the petitioners have no standing to file the instant petitions because they are not directly aggrieved of any of the actions or inactions on the part of the respondents.

The bench said that since the subject controversy, there has been much development on the subject, as the Drug Regulatory Authority of Pakistan Act, 2012, has come into force, and the preambles of both the statutes as to the regulation, import, export, manufacture, storage, distribution and sale of drugs/therapeutics is more or less the same.

The court said that when it comes to the policy in respect of drugs/medicines, the most prioritised aspect to be considered is the health of the people, and the business aspect can be considered on the same touchstone.

The bench said the culture of earning money by selling medicines/drugs is to always have very strict checks and balances, as the Supreme Court had also issued certain directions to the effect, among others, that the business of medicines should be stopped other than in medical stores or pharmacies because it had been noted that medicines were also being sold at groceries, etc.

The court said the sale of drugs has been made licence-based and restrictive, and Chapter III is for the sale of drugs, and its Clause 12 describes the types of licences to sell drugs. The bench said the impugned insertion in Rule 18 has also put certain additional conditions to regulate selling and stocking drugs, and in no way does it appear to have an adverse effect on the business and/or sale of drugs except a system of vigorous checks and balances has been placed.

The court said that the impugned amendments would ensure licences are issued to only the establishments with registered pharmacists; drug sales would be under warranty; only registered pharmacists would be able to get drug sale licences; only authorised agents would deal in drugs; mushroom growth of medical stores would be prevented; and storage conditions would be maintained properly in the respective institutions.

The bench said that it has been noticed that nowadays there is an afflux of spurious and substandard drugs not only in Pakistan but also globally, resulting in life-threatening issues, financial losses to consumers and manufacturers, and the loss of trust in the health system.

The court said that in such a scenario, it is the responsibility of everyone, and not the government alone, rather the petitioners being the associations representing pharmaceutical companies, etc. also have a great responsibility on their shoulders, so they should approach the authorities under the hierarchy of drug regulators for a feedback instead of directly approaching the courts.

The bench said that the federal and provincial governments have attempted to carve out a policy in consultation with all the stakeholders, including the petitioners, and indeed, this menace of spurious and substandard drugs can efficiently be tackled with effective legislation, which has been attempted.

The SHC said the court has not found anything that might infer that any harassment is being caused to the petitioners and/or their members, while no fundamental right concerning trade and business is being infringed upon due to the impugned amendments, as they do not restrict the business of drug sales. The court said that the amendments would prevent the sale of spurious and substandard drugs, and would alleviate the miseries of the people already suffering from certain diseases.