KARACHI, May 28: Despite the orders of the Supreme Court of Pakistan, the Sindh government has been unable to upgrade and strengthen its drug-testing laboratory, which was originally aimed at ensuring quality control through its services.
A source in the provincial health department said that the provincial drug-testing laboratory – if equipped adequately and fully exploited – could play a major role in checking or curbing the manufacture and sale of spurious, substandard, mis-branded, expired, adulterated, counterfeit and unregistered drugs in the province.
“Due to the limited capacity of the only drug-testing lab in the province under the administrative control of the Sindh government, the sampling policy in the case of essential, potent life-saving and fast-moving drugs is lacking on many fronts,” commented another official.
A field officer claimed that now the sampling activities undertaken by the drugs inspectors had also been limited due to the gradually reduced capabilities of the laboratory. “Now the lab prefers to receive a maximum of two samples in a month from each of the provincial government’s drugs inspectors,” the officer added.
Under the Pakistan Drugs Act 1976, an inspector – among other duties – is required to take samples of any drug which is being manufactured, sold, stored or exhibited for sale or distributed in the province for the purpose of tests and analysis through the designated government laboratory.
Referring to advancements in the field of medicine, an expert said there was an urgent need to ensure the availability of latest devices and requisite manpower to analyse and examine the new and sophisticated molecules at the government level.
The laboratory, which is also not properly housed, lacks the capacity to test injectable products. At present, facilities at the Sindh government-run lab are meant for oral medical products only. Injectable products requiring microbiological testing are sent to another federal government laboratory located in Karachi, which already had an outstanding bill of over half a million rupees against the said services, it was learnt.
Manpower shortage
The situation pertaining to trained manpower is also not satisfactory.
“The testing laboratory needs the creation of five posts of analysts and pharmacists, in addition to the appointment of technical and supporting staff against existing vacancies,” said another official, adding that there was a need to improve the workplace environment for the scientists and technical staff.
A source said that the chief minister of Sindh had already approved a request pertaining to the appointment of staff and procurement and purchase of scientific instruments, chemicals, glassware, reference books, animal house, electrical equipment, repairs and validation of instruments and purchase of vehicles for the laboratory in August last, in line with the decisions of the Supreme Court taken about two years back in the context of drug control administration and effective monitoring of drugs sales.
Among other measures, the Supreme Court had also ordered the strengthening of the provincial drug-testing laboratories and provision of requisite facilities therein. The facilities of chemicals, equipment and staff at the Sindh laboratory were provided in 1992; since then it failed to see any major funding or administrative support, said the source.
Shuja-ur-Rehman, director of the laboratory in question, said it was true that due to pending procurement of instruments and filling of vacant as well as approved new posts, the laboratory had been unable to function up to the mark.
He said that at present, about 70 to 75 samples were being tested and analysed on a monthly basis at the lab. However, he immediately added that the government was aware of the situation and had also accorded approval for the upgrade of the lab and hoped that follow-ups would be on the ground shortly.
Another source said that as per an initial estimate, an amount of about Rs68 million was required for the provincial laboratory, but the amount would increase further in view of the rate of inflation and exchange rate of the US dollar.
The Sindh finance department considered the up-gradation of the lab imperative, but at the same time it wanted that the creation of new posts should be rationalised and unnecessary expenditures be avoided.
In the meantime, it was learnt that the relevant persons in the provincial health department’s hierarchy are also considering approaching – once again – the federal health ministry for the acquisition of funds for the lab. “Under the provisions of the Drugs Act 1976, the federal health ministry, which has been maintaining a Central Research Fund, should allow the utilisation of the funds for the up-gradation and establishment of drug research and testing laboratories,” said a high official.
Under the regulatory system spelt out under the Drugs Act 1976, both at the federal and provincial levels, major components including central licensing and registration boards, provincial quality control boards, federal and provincial drugs inspectors and federal and provincial drug-testing laboratories and drugs courts are equally responsible for the quality of drugs produced locally or imported from abroad.
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