1. ' ZULFIQAR AHMAD KHAN, J.---Through the instant petition, the petitioner has impugned Notification bearing SRO No,101(I)/2016, dated 09.02.2016, wherein Respondent No,1. In "partial modification" of clause 4(4)(i) of the Drugs Pricing Mechanism (DPM), created pursuant to Notification No,F.No,9- 12/2014-DDC(P), dated 05.03.2015 issued under Section 7(c)(vii) of the Drugs Regulatory Authority of Pakistan Act, 2012 (DRAP Act), alleging that the said notification is violate of clause (i) of subsection
(4) of Section 4 of the DPM which requires that Maximum Retail Price (MRPs) of generic substitutes of the new chemical entity is to be fixed @ 30% less than Originator brand's MRP.
2. ' Brief. But very important, facts arising out of the perusal of the case are that the instant petition relates to the breakthrough medicine generically known as Sofosbuvir (branded as So valid by Gilead Sciences, Inc. USA) which is termed as a miracle medicine taken orally for the cure of Hepatitis-C, of which there are more than 13 Million sufferers in Pakistan making Pakistan rank as No,2 country in the world on account of prevalence of this deadly disease. Whereas the respondent No,1 being overall custodian of protecting rights of life of the citizens of Pakistan, respondent No,2 is the Drug Regulatory Authority, formed under the above referred DRAP Act for the purpose of providing effective coordination and enforcement of the Drugs Act, 1976 and to bring harmony in inter-provincial` trade and commerce of therapeutic goods. Pursuant to Section 32 of the DRAP Act, the said law is not intended to override other laws and the provisions of the DRAP Act are in addition to and not in derogation of the provisions of the Drugs Act, 1976 and any other law for the time being in force. Also of importance is to mention the Drugs Registration Board (DRB) created pursuant to Section 7 of the Drugs Act, 1976. Section 12 of the Drugs Act, 1976 empowers the Federal Government to fix the MRP at which any drug may be sold and under section 12(3), the Federal Government is also empowered to delegate its authority. Law defines MRP as the ceiling allowing companies the leverage to sell their drugs at any price below this ceiling and does not commercially mean that the MRP is the price at which the drug would be actually sold in the market.
3. ' Pursuant to sections 4 and 41 of the Drugs Act, the Federal Government also formulated the Drugs (Licensing, Registering and Advertising) Rules, 1976, as per Rule 29 (5-A), the Registration Board of DRAP is qualified to request the Federal Government for fixation of the MRP of any drug once the said drug is approved for registration by the Registration Board. For this purpose, pursuant to sections 7, 10 and 12(3) of the Drugs Act, the Federal Government constituted the Drugs Pricing Committee (DPC) vide a notification dated 05.08.2013 and delegated its authority to fix MRP in the hands of the said DPC, resultantly the said DPC acts as the Federal Government and exercises powers of the Federal Government under section 12 of the Drugs Act, 1976.
4. ' The counsel for the Petitioner submitted that his client applied to the Registration Board for the registration of a drug under the trade mark of Soviet (Sofosbuvir 400 mg), which, as mentioned earlier, is the breakthrough medicine having replaced the earlier treatment of Hepatitis-C, which was traditionally treated by taking 24 injection shots by the patient. Now via this medicine, for the first time, cure has been found by taking tablets of Sofosbuvir orally in the complete course treatment for three months, by taking one tablet a day. The counsel for the Petitioner contended that the application for registration of its drug as generic version of Sofosbuvir along with nine other companies' similar generic drugs were scheduled before the DPC for the fixation of MRP on 31.12.2015, which meeting was cancelled and finally took place on 15.01.2016. The counsel further contended that though pursuant to clause (i) of sub-paragraph (4) of Paragraph 4 of the DPM, price of the generics are required to be 30% less than the price accorded to the Originator brand, which pursuant to SRO 410/(1)/2015 was set at Rs,38,000/- (for 28 tablets), MRP for the petitioner's generic version was fixed at Rs,5,868/-, which is about 15.4% of the Originator's MRP. The counsel further contended that such arbitrary fixation of the price for the generic version is in complete violation of the policy mechanism, as well as, the statement given by the Minister of State for Health Services, who had declared that generic be sold @ Rs,26,600/-. Besides what has been stated above, the counsel additionally submitted that while a number of applications for the import of Originator drug were pending before the Respondent No,2, the latter arbitrarily selected prices put forward by a company called Feroze sons Laboratories Limited ("Feroz sons") at the rate of Rs,38,000/- for 28 tablets, whereas other applicants, who offered to import the Originator formula (even from the same supplier in.The USA) at far lesser prices, were ignored. As well as though Feroze sons prices were set vide notification dated 08.05.2015, MRP for the generics were only formulated and issued vide the impugned notification dated 09.02.2016 after the lapse of eight months giving a free ride and monopoly to Feroze sons to exploit poor patients suffering from Hepatitis-C all over the country by charging monopolistic exorbitant prices. The counsel submitted that because of this favoritism, Feroze sons which used to rank at No,24 in the list of pharmaceutical companies of Pakistan with sales of Rs,2.5 Billion reached to the position of No,9 with sales of over Rs,9 Billion with growth of 222% annually. From the accounts of the said company, Feroze sons, the counsel presented a table that showed that while Feroze sons' other products for the period January-December, 2015 were sold at total Rs,3.3 Billion, by mere sale of Sofosbuvir, the company made a windfall of Rs,5.7 Billion at the cost of nations' poor Hepatitis-C sufferers. While Feroze sons was permitted to sell the said medicine at the rate of Rs,1,14,000/- for the full course of three months; we observe from the data available that, in our neighboring country India, the full course of three months. Sofosbuvir was available for Rs,34,000/-. The counsel for the petitioner has prayed that the impugned notification be set aside and the petitioner may be allowed to sell Sofosbuvir @ Rs,26,600/- for 28 tablets, which is 70% of the MRP of the Originator Brand.
5. ' The learned D.A.G appearing on behalf of the federation supported the impugned Notification, wherein generic price is fixed I@ Rs,5,868/- for 28 tablets, contending that from the period when the Originator Brand's MRP was fixed till the date of the instant notification,