P L D 2012 Lahore 222 (PLP)

UMAR ATA BANDIAL, J.

This petition is filed in public interest. Learned counsel for the petitioner has, referred to a tender for anti T.B. medication floated by respondent No.1 at page 23 of the petition which requires a certificate of Bio Equivalence/Bio Availability ("BE/PA") in respect of drugs offered by a bidder to be issued by a laboratory approved by the World Health Organization ("WHO"). Adds that the petitioner has written to nine approved WHO laboratories for conducting necessary tests on the anti T.B. drugs prepared by the petitioner in order to qualify for the competition in the tenders issued by the respondents. No laboratory is willing to conduct the test. He contends that provincial government has imposed an onerous condition that operates to promote the interest of powerful lobbies in the world of pharmaceuticals.

2. In response to the allegations levelled, the provincial government has taken a simple defence that the conditions of eligibility of anti T.B. medication are directed by and in accordance with guidelines given by the Federal Government.

3. Later on the petitioner impleaded the National T.B. Control Programme, Ministry of Health, Government of Pakistan as respondent No.4. The said respondent has filed detailed parawise comments which state in para 6 thereof that four institutions in the country have adequate facilities for conducting BE/BA studies. These are the following:-- (i) Dow University of Medical and Health Sciences at Karachi. (ii) HEJ Research Institute, Karachi University, Karachi. (iii) University of Veterinary and Animal Sciences, Lahore. (iv) Faculty of Pharmacy, Islamia University, Bahawalpur. The said statement is based on the minutes of meeting of the T.B. Drug Management and Regulation Committee held on 29-6-2011 wherein it is reported that the aforenoted four institutions are capable of conducting the necessary tests.

4. Learned counsel for respondent No.4 clarifies that the four institutions are functioning in accordance with the guidelines provided by WHO and therefore there is no prejudice to public interest caused by allowing such institutions to conduct B.E/B.A tests.

5. It appears that the Federal Government has recognized four domestic institutions to conduct the necessary tests for a drug which is essential for preventing a dangerous disease and must be readily available across the country at all level at affordable prices. However, it is noted that beyond the minutes of the aforenoted committee, there is no formal document recognizing the four institutions or otherwise empowering them to conduct tests. Therefore, in order to make the decision of the Federal Government effective and beneficial, it is essential that a formal instrument, notifying the four institutions recognizing them as the approved institutions for conducting B.E/B.A tests, be issued. The said step is necessary so that the domestic capability in drug manufacturing, which necessarily would reduce the pricing of the drugs available for public use, be empowered and supported so that the necessary medication is available across the country to all levels of society.

6. The necessary notification be issued before end of the current financial year. Petition Disposed of. M.H./P-2/L Order accordingly.