DRAP’s regulatory approach questioned as PAAM chairman highlights pharmaceutical quality alerts

Chairman of the Pakistan Association of Alternative Medicine (PAAM) Kashif Aslam Malik has strongly criticised the Drug Regulatory

LAHORE:  Chairman of the Pakistan Association of Alternative Medicine (PAAM) Kashif Aslam Malik has strongly criticised the Drug Regulatory Authority of Pakistan (DRAP), alleging that regulatory shortcomings in the pharmaceutical sector have raised serious questions about the authority’s quality-control mechanisms.

Malik claimed that while DRAP has struggled to ensure consistent quality standards in the allopathic pharmaceutical market, the authority is adopting a disproportionate approach towards the alternative and homeopathic medicine industry. He alleged that regulatory measures being proposed for alternative medicine manufacturers could place significant operational and financial burdens on the sector.

According to Malik, DRAP has circulated a 128-page draft of the Alternative Medicines and Health Products (AMHP) Rules 2026, which he said contains infrastructure and manufacturing requirements that may be difficult for homeopathic manufacturers to implement.

He specifically objected to proposed requirements relating to pharmaceutical-grade heating, ventilation and air-conditioning systems at homeopathic manufacturing facilities. Malik argued that such requirements need to be assessed in light of the manufacturing processes and materials used by alternative medicine producers. He further claimed that certain proposed infrastructure requirements could create safety concerns in facilities where alcohol-based production processes are involved.

Malik described the proposed regulatory framework as an attempt to place excessive restrictions on the alternative medicine sector and urged the authorities to review the draft in consultation with industry stakeholders.

Questions over quality-control system

To support his criticism, the PAAM chairman referred to official reports and alerts issued by Punjab’s Directorate of Drugs Control (DDCP) and Drug Testing Laboratories (DTL).

He claimed that between September 1 and September 18, 2026, the provincial authorities issued emergency recall, stoppage or quality-related alerts involving more than 15 pharmaceutical products registered with DRAP.

According to the documents cited by Malik, the products mentioned in the alerts included Inj. Glycosting manufactured by Bajwa Pharmaceuticals, which was reportedly associated with severe bradycardia, or a significant reduction in heart rate. Other products cited included Inj. Pivacain-SP and Inj. Isobaj, which were reportedly found to contain visible particulate or glass particles.

Malik also referred to an alert concerning pediatric syrup Azee Vit manufactured by Obsons Pharma and another concerning crepe bandages, which he claimed were classified as spurious products. He further cited Inj. Pd-Meek by PDH Labs, which he said had entered the market before completion of required sterility testing.

Other products mentioned in his statement included Tab. Bemin, Bricit 10mg, Inj. Mecodax and Inj. Sterile Water, which he said were identified by the relevant authorities as substandard or adulterated.

The PAAM chairman questioned how products allegedly failing quality checks could reach the market despite Pakistan’s regulatory framework, arguing that the reported cases warranted closer scrutiny of existing monitoring and enforcement mechanisms.

Call for balanced regulation

Malik also highlighted the size of the pharmaceutical industry, noting that the global pharmaceutical market is valued at more than $1.6 trillion, while Pakistan’s allopathic pharmaceutical market has been estimated at over Rs700 billion.

He argued that regulatory authorities should ensure effective enforcement of quality standards across all categories of medicines rather than placing disproportionate pressure on one segment of the healthcare sector.

Malik further claimed that a significant portion of Pakistan’s population relies on natural, alternative and affordable healthcare remedies. He called for consultation with industry representatives before finalising the AMHP Rules 2026 and urged DRAP to adopt a regulatory framework that, in his view, addresses safety and quality concerns while remaining practical for manufacturers.

The claims regarding the cited products and regulatory measures are attributed to Malik and the government documents he referenced; the allegations do not, by themselves, establish wrongdoing by DRAP or the manufacturers named.