The cost of drugs comprises a major component of the overall cost of healthcare in countries like Pakistan, especially where there are no health insurance systems. In this context, there is a long-going debate on the availability/viability of generic drugs versus branded drugs in the market. The rationale is that the generic drugs cost much less than the branded ones that are manufactured often by those inventing these and have almost the same efficacy. The inventing companies claim higher price to offset the cost of research and development and clinical tests they conduct.
Anyhow, there is a quarter that calls to restrict physicians from prescribing drugs with brand names. They demand that medicines be prescribed by generic names. It also alleges that a large number of doctors would prescribe expensive brands in exchange of favours extended to them and at the cost of patients.
The issue is currently in the news, courtesy a case being heard by the Lahore High Court (LHC). A pharmaceutical company Generic Pharmacy made the Federation of Pakistan a respondent in a petition filed in December 2016 regarding registration of medicines under proprietary names, in violation of the country’s drug laws, and not under generic names.
Noor Muhammad Mahar, the owner of the company and spokesperson Pakistan Pharmacists’ Association (PPA), tells TNS that Section 7(8) of the Drug Act 1976 states that single-ingredient drugs shall be registered generally by their generic names while compound drugs shall be registered generally by their proprietary names. “The single-ingredient drugs”, he says, “mean drugs containing one active ingredient and compound drugs mean drugs containing more than one active ingredient”.
Mahar complains that the concerned authorities have registered almost 70,000 single-ingredient drugs of different companies with their proprietary names in Pakistan. “As there are all brand names the physicians prescribe these.” He says the court has sought explanation from respondents as well as issued notices to around 350 pharmaceutical companies that have got their products registered under brands in violation of this law. Citing an example, he says a pack of same-salt medicine to treat hypertension may cost anything from Rs30 to Rs300 depending on the brand that is marketing it.
He shares that the Drug Regulatory Authority of Pakistan (DRAP) is also under the scanner but it’s slow in responding because its former Chief Executive Officer (CEO), Aslam Afghani, has been removed by the Supreme Court of Pakistan (SCP). He says the allegation against him was that he had favoured pharmaceutical companies in which he had his financial stakes. “How can you expect fair play from such an organisation?”
Sheikh Kaiser Waheed, Chairman Pakistan Pharmaceutical Manufacturers’ Association (PPMA), objects to Mahar’s assertion. He believes the physicians shall not be deprived of their right to prescribe best medicines available in the market. He thinks the concept of prescribing generic medicines is workable in developed countries where literacy and quality control levels are high. This, he says, is no way the case here.
In Pakistan, he says, the reputed manufacturing companies assume the responsibility to ensure post-marketing surveillance and make surprise visits to the pharmacies and medical stores selling their products. “During these visits”, he says, “they inspect the expiry dates of medicines, whether the fridge items have been properly stored, if their seals are intact, and so on. There are companies that do not ensure quality and it will be a prerogative of the shop staff to give these to patients if only generic names are mentioned on the prescriptions,” he adds.
Sheikh Ansar, Director Pharmacovigilance at DRAP tells TNS that though it is not yet binding on physicians to prescribe only the generic names, certain rules are there to give patients a choice and watch their interests. For example, he says, “The Drugs (Labeling and Packing) Rules, 1986 call for giving equal prominence to both the proprietary name and the generic name of a drug on the outer and inner label/packing. These particulars shall appear either in print or in writing conspicuously,” he adds. His point is that even if a physician prescribes a branded drug, the patient can ask for a cheaper generic alternative with the name of the same salt mentioned on it.
Ashraf Nizami, Central President, Pakistan Medical Association (PMA) is of the opinion that the doctors shall prescribe generic names but for that there shall be an enabling environment. Explaining his point, he says, “If the doctors start prescribing generic medicines in every case many patients will not be able to find them. A major reason for this is that the non-qualified staff at medical stores is often unaware of the exact generic alternatives of a popular brand,” he adds.
Nizami says, “because of intensive brand promotion activities, the cost of branded medicines increases manifold — beyond common man’s reach. Though there is a ban on advertising of medicines on mass media,” he says, “the objectives are achieved with undue favours to doctors who prescribe branded medicines of a particular company.”
He recalls that during Zulfikar Ali Bhutto’s government, the then socialist Minister of Health Sheikh Rasheed Ahmed introduced the famous Generic Drugs Act which aimed at breaking monopolies and bringing the prices down. The policy achieved results but had to be reversed later on due to the influence of the affected parties.
Nizami cites the example of Shaukat Khanum Cancer Hospital where he shares the doctors have been directed to prescribe medicines by their generic names. The hospital is quite strict in this regard and even asks experts to use generic names of drugs in the research papers they read at symposia held there.