September Issue 2008

By | News & Politics | Published 15 years ago

“Reports issued by the government’s drug testing laboratories become the fulcrum upon which cases are framed against the violators”
– Dr Sagheer Ahmed, Provincial Minister for Health, Sindh

Q: What steps does the provincial ministry intend to take to curb the problem of counterfeit and spurious medicines in Sindh?

A: In December 2005, the provincial health department issued a notification under the provison of Section II (5)(b) of the Drug Act 1976, which enabled speedy action to be taken against spurious, unregistered and uncertified medicines, allowing drug inspectors to lodge an FIR and prosecute cases in the drug courts of Sindh.

Q: Apparently Katchi Gali in Karachi is notorious for such activities. Why hasn’t any concrete action been taken yet?

A: Clandestine manufacturing, such as that of spurious drugs, can be carried out even in a room. The drug inspectors are few in number and have to cover an entire district. Also, they are ill-equipped. However, steps are underway to equip them with all the tools demanded by their prescribed job. A summary to that effect has already been approved by the Sindh chief minister, and is now pending with the finance department. Amendments to the drug rules have also been proposed to curb the activities going on at Katchi Gali. In the past, raids have been conducted at Katchi Gali and Aswani lane in Hyderabad, and shops were sealed and stocks of unlicensed, spurious, substandard drugs were seized. But with the amended rules, these actions will become more concrete.

Q: In all other provinces, the bill of warranty that regulates distributors and wholesalers, has been introduced. When will this be brought into effect in Sindh?

A: It is under specific consideration. As soon as the gazette notification of these rules is issued, action will become very visible.

Q: What kind of market surveillance and monitoring is carried out by the provincial ministry vis-a-vis the sale of drugs and the practice of doctors?

A: The drug inspectors, by the authority vested in them under Section 18 of the Drug Act 1976, pick up samples from all sales and manufacturing outlets which are then sent to the government’s testing laboratories. The test reports issued by the laboratory become the fulcrum upon which cases are framed against the violators. The practice of doctors falls under the strict vigilance of the director general health and the concerned EDO health of each district.

Q: Pakistan is among the few countries in the world where life-saving drugs are sold over the counter, without prescriptions. Why is that so?

A: Steps are being taken to bind doctors into issuing proper prescriptions in triplicate. Also, drug inspectors have been inspecting sales outlets to make sure that no sale is made without a prescription. The sales outlets, through the amendment in the Sindh drug sale rules, are required to have printed cash memos whenever they sell a prescribed drug. The cash memo is to be provided to the customer, specifying the name of the patient, strength of the drug, the batch number, name of the manufacturer and the expiry date of the drug being sold.

Q: Paanwalas, too, are selling medicines, even if it is just Panadol. Why is the sale of drugs not regulated in a way that only licensed shops can sell them?

A: The drug inspectors have been issued strict orders to stop sales made on unlicensed premises and, as mentioned earlier, they also have the authority to book such stores and immediately file a case in the drug court. This step will act as a deterrent for the sale of medicines without a license.

Q: Quackery lends a hand in the promotion of counterfeit and spurious drugs. Many unlicensed doctors and GPs operate in bastis. If a person is found running such a practice, what are the consequences and can there be an immediate shutdown of their clinic?

A: The EDOs and the director general health, under the Pakistan Medical & Dental Council Ordinance issued in 1982, are fully competent to take action against unlicensed practitioners. However, adequate rules for the matter have yet to be framed to identify the nature of prohibition, specify the penalty/punishment of the offender and prescribe a special court, entrusted to take cognisance of such cases.

Q: When counterfeit, spurious or substandard drugs are seized from a shop or market, why can’t it be shut down instantly? And what is the punishment for somebody who is manufacturing or selling it?

A: The Drug Act provides for taking action against the violation of the Drug Act rules only. The constitution of Pakistan provides security for conducting business to every citizen of the country and action can only be taken against detected violation. If there are a thousand other products displayed for sale in a shop and these are not in violation of the law, any action taken against a shop for some items that are in contravention of the law would jeopardise the guarantee provided to the shop owner, under the constitution.

Q: Many people have voiced their concern regarding the limited number of drug inspectors, their lack of transport facilities and monetary incentive, and the fact that even when they do conduct raids, either they are faced with law and order problems, as those involved in the activities are very influential, or they are bought over. What will be done to address this issue?

A: Notice has been taken of the shortage of drug inspectors and for this purpose, another 16 have been approved. In addition, the provision for transport, budget, a proper office with telephone, fax, computer, printer/internet facilities and other requisites for their optimum performance are also on the list. The federal government has formed a committee to address this issue and is preparing a proposal in this regard.

Q: It is believed that hospital pharmacies and the large reputable pharmacies of the cities, such as those in Karachi, are unregulated and drug inspectors rarely ever pick up samples from there because they are prevented from doing so. Why do the drug inspectors not have the adequate manpower and authority to do so?

A: Necessary amendments in the Sindh drug rules have been proposed to bring the hospital pharmacies, both in the private and public sector, and all others who are procuring, storing and distributing drugs, under its provision. Once these rules are promulgated, the drug inspectors will be able to monitor them in the same manner as all the other medical stores. All hospitals and other institutions will then have to acquire a drug sale license and will be regulated by the same rules as all other medical stores.

Farieha Aziz is a Karachi-based journalist and teacher. She joined Newsline in 2007, rising to assistant editor. Farieha was awarded the APNS award for Best Investigative Report (Business/Economic) for the year 2007-2008. She is a co-founder and Director at Bolo Bhi, an advocacy forum of Digital Rights.