Government to conduct third-party audit of drugs manufacturing units

Author: By Suleman Chaudhry

LAHORE: The Punjab government has decided to conduct a detailed inspection of all pharmaceutical manufacturing firms located across the province to check good manufacturing practices (GMP) and ensure the provision of quality medicines to the masses.

In this connection, local and international audit firms have been invited to conduct complete inspection of drug manufacturing units situated within Punjab, while stern action would be taken against those firms working in violation of the drug act, it was learnt.

Well-informed sources privy to this development told Daily Times that the Punjab government was undertaking wide-ranging reforms to improve the healthcare service delivery. As part of the reform services, one of the initiatives was to monitor the quality of pharmaceutical products being manufactured in Punjab.

Sources said the Primary and Secondary Healthcare (P&SHC) Department intended to involve national/local audit firms/service providers having adequate experience of audit/inspections/third party audits, along with drug control regime of the Punjab government, to inspect drug manufacturing units in Punjab (300 units approximately) as well as manufacturing units outside Punjab (may optionally be inspected as part of ensuring quality medicines for public procurements of P&SHC Department).

It is pertinent to mention that as many as 11 samples of medicines from 10 national and multinational pharmaceutical companies, including Tab cardi-5 by Benson Pharma, Islamabad, Tab AR Naproxen 550 and Tab Ciproval 500mg by Arson Pharma, Lahore, have been failed by the Drug Testing Laboratory (DTL). Likewise, medicine named Sol Kleen Enema by Nabi Qasim, Karachi, and inhaler Salbo HFA by Getz, Karachi, were also declared substandard. Samples of Syp Alercure 60ml by Life Pharma, Multan, and Susp Maxil 125mg/5ml by Macter, Karachi, also failed to pass the test. Susp Cefusave 125mg/5ml by Medisave, Lahore, Inj Aclova 250mg by Allied distributor, Karachi, Tab Augmiclave DS and Clavunate by Lisko, Karachi, and Soda Glycerine by Lahore Pharma were declared not having standard quality.

Sources said the government, on back of the recent samples, has now decided to conduct complete inspection of Pharma units across the province. According to the criteria, selected firm shall be responsible for inspection of pharmaceutical manufacturing facilities, besides ensuring that GMP was followed across all pharmaceutical units. Sources said each inspection and monitoring team must comprise at least five members, including GMP auditors/pharmacists, analytical experts, biomedical engineer and pharmaceutical experts on quality control and assurance, adding that physical inspections and audits of a manufacturing unit must be done on a random risk based model.

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