' ZULFIQAR AHMAD KHAN, J.---Being aggrieved with the import policy of drugs announced by the Policy Board of Drug Regulatory Authority, Pakistan ("DRAP") in October 2013, the petitioner who is a representative body of drug importers, wholesaler and retailers has agitated this instant petition praying that the said Policy be set aside and directions be given to the respondents to follow Drug (Licensing, Registering and Advertising) Rules, 1976 ("the Rules").
2. Upshot of the contention of the learned counsel for the petitioner is that the said Policy is discriminatory vis-a-vis the procedure provided for the importers of Active Pharmaceutical Ingredient ("API") vs the importer of finished drugs (whose interests the petitioner represents). In particular, the learned counsel drew court's attention to item (i) of the Policy which provides that "product specific inspection of manufacturer abroad will be carried out before grant of registration" whereas, no such requirement of manufacturers' premises inspection is required in the said Policy for the importers of APIs, which per the counsel's contention are also imported from the overseas.
This added requirement, per the learned counsel, at one hand adds extra cost, at the same time delays process of registration of the new finished-imported drug. However, when the counsel's attention was drawn to paragraphs (iv) and (v) of the said Policy, which respectively provide as under:--
(iv) Inspection of all manufacturers abroad will be conducted except for products manufactured and approved for sale by US-FDA, EMA, or regulatory bodies of Japan, Australia, Health Canada, and Switzerland, any of the regulatory bodies of erstwhile Western Europe or three stringent regulatory bodies of erstwhile Eastern Europe, which shall be exempted from the inspection of the manufacturing unit abroad.
(v) The product pre-qualified by the World Health Organization will also be exempted. ' the learned counsel said that many finished drugs are imported from countries not listed in the above clauses, as the above list of the countries isn't very exhaustive thus grievances of the petitioner persists.
3. To answer the contention as to the different procedures adopted by DRAPE, we would have to consider the provisions of the Drug Act, 1976 and the Rules. Pursuant to the Act, the Federal Government has privilege to regulate the import and export of drugs and to prescribe manner therefor and for those purposes, make such orders and issue such policies and directions to the importers and exporters as it may deem fit. The Act requires all drugs to be registered in accordance with such conditions and procedure, as may be prescribed. As per Rules, there are various kinds of licenses which are granted in respect of drugs manufacture and import in Pakistan. These include; (i) licensee to manufacture by way of basic manufacture; (ii) licensee to manufacture by way of semi-basic manufacture; (iii) licensee to manufacture by way of formulation; (iv) licensee to manufacture by way of repacking; and (v) licensee to manufacture for experimental purposes.
4. While pre and post-requisites for each of the above license are different, the license granted to make use of API are those listed as (ii) and (iii) above, however, license needed to import finished drugs are of specialized type and their procedure is provided for in the Drugs (Import and Export)
Rules, 1976 ("Import Rules"). Pursuant to Rule 3 of the Import Rules 3, finished drugs are to be imported subject to the condition that the importer possesses a license to sell by Way of retail wholesale the drug intended to be imported by him and has adequate facilities for proper storage to preserve its properties; (ii) the importer within fifteen days of establishing the letter of credit, intimates such action on the prescribed form; (iii) the drug is required to be imported in containers intended for retail sale or supply to hospitals, dispensaries or such other institutions; and (iv) the drugs shall be imported against indents issued by the authorized inventors or local agents of the manufacturers.
5. One of the requirements for obtaining import license for the import of the finished drugs is that an undertaking from the manufacturer abroad has to be provided certifying that the applicant has made a contract with the manufacturer for import of the specified drug(s) and that the manufacturer is a bona fide licensed manufacturer of the drugs at the premises specified in the form and the manufacturer is liable to report change, if any, in the said premises. This requirement of registration of manufacturing facility (once having inspected) aims ensuring compliance of good manufacturing practices carried on at the manufacturer's premises, which is a routine pre- requisite from drug manufacturer duly approved by the World Health Organization ("WHO") and United States Food and Drug Administration ("US FDA"), as well as, followed in many countries of the world, including Pakistan, We therefore don't see inclusion of product specific inspection of the manufacturer abroad for finished-drug import violative of any statutory provisions of the aforementioned laws that could give rise to this instant constitutional petition alleging that the said policy be held ultra vires on any such account.
6. The other contention of the learned counsel for the petitioner is leveled on the ground of unfair treatment. The counsel alleged that since there is no such requirement of the inspection of the foreign manufacturers of APIs, why the bar has been raised for the finished-drug importers? In support of this assertion the counsel placed before the Court a copy of Program 7356.002F of US FDA contenting that as per the said document, no distinction is made between. An API and a finished drug. To answer this question, we will need to study APIs in little more details.
7. Briefly speaking, active ingredients are the substances in drugs that are responsible for the beneficial health effects experienced by patients. The active ingredient in a pharmaceutical drug is called an active pharmaceutical ingredient (API). The quality of APIs in a drug has a direct effect on the safety and efficacy of that drug. Poorly manufactured and contaminated APIs have been associated with negative health outcomes, including death, in a number of incidents over the past decades. For this reason, most countries around the world are now regulating manufacturing of APIs through Current Good Manufacturing Practices ("CGMP") programs. Since detailed deliberation on these programs is beyond the scope of this judgment, however, objective of a typical CGMP is aimed at providing complete gitidnice regarding good manufacturing practice for the manufacturing of APIs under appropriate system for managing quality of drugs manufactured.
Such a program helps ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. During CGMP all processes of manufacturing from the receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs are considered, which includes detailed visit to the manufacturing facilities of APIs and cataloging all the processes. By WHO and US FDA, for example, these CGMPs are well defined responsibilities of the manufacturer and are governed by laws and procedures. Since all APIs are to be manufactured in conformance with CGMP in many countries of the world, that is the reason that no distinction (e.g. By US FDA) is made between an API and a finished pharmaceutical as both are required to be manufactured after passing through stringent and rigorous measures prescribed by CGMP in USA, thus putting an imported API to the same test of manufacturer's good practices doctrine in the US market is of no use, since API has already been manufactured using a CGMP (which includes a number of inspections of the manufacturer's production facilities), however, there will always be a preferable need for the manufacturer's Inspection for a finished-drug import, unless the finished-drug is originating from any selective countries having established and proven CGMP in place like, USA, Japan, Australia, Canada, Switzerland and selected countries of Western Europe and the drug has been pre-qualified by WHO (which are the exemptions already given in paras. (iv) and (v) of the impugned policy).
8. Notwithstanding the pre-inspection of the manufacturing facilities in respect of APIs imported in Pakistan as a part of CGMP, once imported into Pakistan, the mechanism of stringent inspections of the local manufacturers' facilities are conducted at several instants as per the standard operating procedure prescribed by the Act and the Rules. One of such inspection is made pursuant to Rule 10, where the Central Licensing Board before issuing a licence causes the premises in which the manufacture is proposed to be conducted to be inspected by itself or by its sub-committee or by a panel of inspector or experts appointed by it for the purpose, which are required to examine all portions of the premises and the plant and appliances; and to inspect the process of manufacture intended to be employed and the means to be employed for standarising, if necessary, and analyzing substances to be manufactured and enquire into the professional qualifications 'of the technical staff employed. In cases where the inspection is carried out by a subcommittee or panel of experts of Inspectors appointed, the said subcommittee is required to forward to the Central Licensing Board a detailed report of the result of the inspection. Such an inspection could take place any time also during the process of manufacturing of the drug using API, as well as, at the time of renewal of the license.
9. With regards the allegation of discrimination, petitioner's case is also not suited as per the established principles requiring that A discrimination has to be shown vis-a-vis the same class and category, and not the whole world around (1996 M LD 1136). As, in the instant case, class and category for finished-drug imports and API are completely different and governed by different Rules as discussed in the foregoing, that being the factual position, it establishes that the policy items impugned in the instant petition are perfectly in accordance with the rules and the grievance of the petitioner appears to be out of place since no discrimination can be seen in the instant case on this ground also.
10. We therefore on all the counts referred herein above don't see any merit in the contentions raised in the instant petition, as the impugned policy seems to be completely in line with the legal framework established by the afore-referred laws, besides being a matter of policy of the government.
11. We therefore dismiss the present constitutional petition, being devoid of any merit.