Research › Browse › Judgment

Supreme Court of India · body

2015 DIGILAW 62 (SC)

Kalpana Mehta v. U. O. I.

2015-01-13

DIPAK MISRA, PRAFULLA C.PANT

body2015
ORDER On 12th August, 2014, Kalpana Mehta v. Union of India, WP (C) No. 558 of 2012, order dated 12-8-2014 (SC) while dealing with the controversy at length, this Court had posed the following questions: "(i) Whether before the drug was accepted to be used as a vaccine in India, the Druges Controller General of India and the ICMR had followed the procedure for said introduction? (ii) What is the action taken after the Parliamentary Committee had submitted the 72nd report on 30.08.2013? (iii) What are the reasons for choosing certain places in Gujarat and Andhra Pradesh? (iv) What has actually caused the deaths and other ailments who had been administered the said vaccine? (v) Assuming this vaccine has been administered, regard being had to the nature of the vaccine, being not an ordinary one, what steps have been taken for monitoring the same by the competent authorities of the Union of India, who are concerned with health of the nation as well as the State Governments who have an equal role in this regard? (vi) The girls who were administered the vaccine, whether proper consent has been taken from their parents/guardians, as we have been apprised at the Bar that the young girls had not reached the age of majority? (vii) What protocol is required to be observed/followed, assuming this kind of vaccination is required to be carried out?" 2. After posing the questions, the Court had proceeded to express thus: "Regard being had to the aforesaid concerns, which are posed in the aforesaid questions, we think it apposite that the State of Gujarat, State of Andhra Pradesh and State of Telangana be impleaded as parties. Hence, liberty is granted to the petitioners to take steps to serve standing counsel for the State of Gujarat, Andhra Pradesh and Telangana in both the petitions. Dasti, in addition, is permitted. Be it stated, their appearance shall be in respect of both the petitions. At this juncture, a submission was made to the effect that manufacturing companies, M/s. Glaxosmithkline Asia Pvt. Ltd. and MSD Pharmaceuticals Pvt. Ltd. (Respondent no.7 and 8 respectively in W.P.(C) No. 558/2012) should be served. Mr. Jyoti Mendiratta, Advocate, undertakes to take appropriate steps to effect service on the said companies. Dasti, in addition, is permitted. At this juncture, a submission was made to the effect that manufacturing companies, M/s. Glaxosmithkline Asia Pvt. Ltd. and MSD Pharmaceuticals Pvt. Ltd. (Respondent no.7 and 8 respectively in W.P.(C) No. 558/2012) should be served. Mr. Jyoti Mendiratta, Advocate, undertakes to take appropriate steps to effect service on the said companies. Dasti, in addition, is permitted. Learned counsel for the petitioners are also granted liberty to effect service on the concerned Ethics Committee of the all the three States. This Court hopes and trust that on the next date of hearing, the Standing Counsel of all the States shall remain present and argue the matter. At this juncture, we are obligated to state the Union of India, who is required to assist this Court in proper perspective, shall direct its competent authority to produce the file by which the Drugs Controller General of India had approved the vaccine for introduction in India. Mr. Suri, learned senior counsel for the Union of India will produce the said file. Additionally, the relevant documents shall also be provided to the concerned counsel for the petitioners. The Learned counsel for the Union of India shall apprise this Court what steps have been taken by the Union of India on the basis of the Parliamentary Committee Report. Counsel for the State, who have appeared, shall file their counter affidavits within a period of four weeks. The Union of India shall also file their counter affidavit in W.P.(C) No.921/2013 within four weeks. Rejoinder affidavit, if any, be filed within two weeks therefrom. By the same time, rejoinder affidavit to the counter affidavit filed by PATH International be filed. Mr. Dipank Yadav, Advocate, who appears for ICMR shall also produce the file of ICMR dealing with this vaccine by the next date. Let the writ petitions be listed on 28.10.2014." 3. Mr. Colin Gonsalves, learned senior counsel appearing for the petitioner in W.P.(C) 558 of 2012 and Mr. Anand Grover, learned senior counsel for the petitioner in W.P.(C) No.921 of 2013, have drawn our attention to the 81st Report dated 22nd December 2014 of the Parliamentary Standing Committee. On a perusal of the said Report, we find some defects being noticed and certain suggestions have been given. Mr. Anand Grover, learned senior counsel for the petitioner in W.P.(C) No.921 of 2013, have drawn our attention to the 81st Report dated 22nd December 2014 of the Parliamentary Standing Committee. On a perusal of the said Report, we find some defects being noticed and certain suggestions have been given. Mr. R.S. Suri, learned senior counsel appearing for the Union of India, shall obtain instructions from the competent authorities of the Union of India as to what steps are being thought of on the basis of the aforesaid Report. 4. The next issue that we intend to address today relates to the "concept of consent" and the resultant deaths. It is submitted by Mr. Gonsalves that though innovative explanations have been given by stating that some girls in the States of Gujarat and Telangana have expired due to snake bite and fever, yet in actuality, it is due to administration of vaccination. It is also urged by Mr. Gonsalves and Mr. Grover that though the number of vaccinations that have been carried out for the purpose of experimentation, there is no data with regard to the adverse effects that have been faced by the young girls. 5. Mr. R.S. Suri, learned senior counsel appearing for the Union of India, Ms. Hemantika Wahi, learned counsel appearing for the State of Gujarat and Mr. Uday Sagar, learned counsel appearing for the State of Telangana, shall state by way of affidavit, what is the procedure to be protocol to be followed while obtaining consent. The stand taken by the Union of India and the States shall be clear and in consonance with law, for the affidavit is not expected to be filed in contravention of what has been envisaged in law. 6. At present, we are obliged to state that the present public interest litigation has to be perceived from the point of view of rectification, if any, and caution for the future. When we use the word 'rectification', we mean apart from the questions which have been posed earlier, the factum of consent and the procedure followed in consent and the sequitur of such consent are to be kept in view. The 'caution' would convey what steps have to be taken in future so that these kind of grievances do not arise. 7. The 'caution' would convey what steps have to be taken in future so that these kind of grievances do not arise. 7. The Learned counsel appearing for the Union of India and the States of Gujarat and Telangana shall file their respective affidavits keeping in view the directions given herein-above. To elucidate, the affidavit filed by the Union of India shall contain explicitly : (i) what steps they intend to take on the basis of the report given by the Parliamentary Standing Committee, (ii) what is the procedure to be followed for the purposes of consent and what steps are required to be taken to find out the sufferings, if any, by the persons who were vaccinated, and (iii) the liability of compensation, if any, to be paid and whose liability it would be. 8. Let the requisite affidavits be filed within four weeks hence. Rejoinder, if any, be filed within two weeks therefrom. List the matter on 21st April, 2015.