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For the public at large, the question of spurious or more popularly known ‘Ja’alee’ drugs keeps popping up in a very troubled way. Being a veteran of Pharma industry, I consider it appropriate to write on this subject and clarify about various aspects of the problem.
Some time back, I heard a statement on TV from Mr. Gillani, Head of Transparency International Pakistan. He said, “80% drugs in Pakistan are Ja’alee”. It is a rather irresponsible statement coming from a responsible person. There are no statistics to support this statement; it is just hearsay. More recently, WHO coordinator in Pakistan, Mr. Khalid Saeed echoed similar sentiment in a seminar. This is more serious because Mr. Khalid Saeed is an insider of the industry and the regulator. General public has also come to believe that most drugs available on the market are Ja’alee.
Let us first define what is Ja’alee.
Drug Regulatory Authority Pakistan (DRAP) is authorized to regulate and control the veterinary and human medicines, nutritional supplements, nutraceuticals, and medical devices. DRAP registers all these products, regulates the import and sale of active ingredients, controls the prices of human medicines only, and regulates the sales of manufactured and imported products. It is a handful. We shall also see later whether DRAP is adequately equipped to do this huge task in the manner that it is supposed to be done.
The governing law for medical business is Drug Act 1976. It was enforced in April 1976 by the then PPP government led by Z. A. Bhutto; the Health Minister was late Sheikh Rasheed. Prior to this, the PPP government had introduced Generic Policy. As per this policy, all medicines were to be labeled and prescribed by the generic name (the active ingredient name); no brands please. For example, Paracetamol would be sold as Paracetamol and not as Panadol or Calpol or other hundred such names. The intent of Generic policy was to counter the rise of brands through marketing activities, and to reduce the influence of marketers on prescribing physicians. Good intentions, however, need proper planning, resources, execution and monitoring. Generic policy was a non-starter from the being, but it did drag for about three years. Finally, the government abandoned it and introduced Drug Act 1976, which brought the Brands back. This is still the law, though several amendments and additions have been done to cater emerging needs.
Please visit https://www.ppma.org.pk/wp-content/uploads/2016/04/The-Drugs-Act-1976-3.pdf to read the full text of Drug Act 1976.
In the Chapter 1, among ‘Definitions’, the Act defines four problem categories. These are reproduced below.
- (a) “Adulterated drugs” means a drug (i) which consists in whole or in part of any filthy, putrid or decomposed substance or which contains any foreign matter, vermin, worm, rodent or insect; or (ii) which has been manufactured, packed, or held under unsanitary conditions whereby it [has] been contaminated with dirt, filth or any other foreign matter or whereby it may have been rendered injurious to health; or (iii) the container of which releases any poisonous or deleterious substance which may render the contents injurious to health; or Page 2 of 32 (iv) which bears or contains as an ingredient a substance other than the prescribed substance; or (v) with which any substance has been mixed or packed so as to reduce its quality or strength or for which any substance has been substituted wholly or in part;
- (f) “counterfeit drug” means a drug or the label or outer packing of which is an imitation of, or resembles or so nearly resembles as to be calculated to deceive the label or outer-packing of a drug of another manufacture;
- (s) “Misbranded drug” means a drug (i) which is not labelled in the prescribed manner; or (ii) on the label or labelling of which any word, statement or other matter or information required by the rules to appear on the label or labelling is not prominently placed with such conspicuousness (as compared with other words, statements, designs, or devices on the label or labelling) and in such terms as may render it likely to be read ‘and understood by the ordinary individual under customary conditions of purchase and use; or (iii) which is not labelled with such directions for use and such warnings against use in indications where its use may be dangerous to health, or against unsafe dosage or duration of administration or application in such manner and form as are necessary for the protection of users or as may be prescribed; or (iv) the label or container of which, or anything accompanying which, bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular; or (v) which is so coloured, coated, powdered or polished that damage is concealed, or which is made to appear of better or greater therapeutic value than it really is; or (vi) which is manufactured according to the specifications of a particular pharmacopoeia or any other document as may be prescribed and the label does not bear the name of that pharmacopoeia or document;
- (z-b) “Spurious drug” means a drug (i) which purports to be a drug but does not contain the active ingredient of that drug; or (ii) which purports to be the product of a manufacturer, place or country of whom or of which it is not truly a product; or (iii) which is imported or exported or sold or offered or exposed for sale under a particular name while actually it is another drug; or (iv) the label of which bears the name of an individual or company purporting to be its manufacturer or producer which individual or company is fictitious or does not exist;
When Ja’alee drugs are talked about, it is mostly a reference to 1, 2 & 4. #3 is also relevant but is more technical.
You can see that there are several ways in which a drug may be different from the one prescribed to you by your doctor. Medicine business is a serious business and must be taken very seriously.
In the next posts, we shall see the following topics to comprehend the problems and suggestion for solutions.
- Licensing and Registration
- Pakistan Pharma Market
- Pharma Industry in Pakistan and Neighboring Countries
- Pharma Marketing
- Working of DRAP
- Where it may go wrong
- Thoughts on Solutions