The Supreme Court on Monday issued notice to the Centre on a PIL seeking to quash licensing of two vaccines for cervical cancer treatment on the ground that the approval for their use was done without adequate research on safety.
A bench of justices K.S. Radhakrishnan and Dipak Misra agreed to hear the plea after it was alleged that the Drugs Controller issued licences for the vaccines without adequate research on safety as directed by Parliamentary Standing Committee on Health and Family Welfare in 2010.
Petitioner Kalpana Mehta and other health activists alleged that the vaccines — Gardasil and Cervarix — are unproven and hazardous human papilloma virus (HPV) vaccines being marketed in India by MSD Pharmaceuticals Pvt. Ltd. and GlaxoSmithKline Ltd.
The HPV vaccine prevents infection with certain species of human papillomavirus associated with the development of cervical cancer.
The court passed the order on the petition pleading that licences be suspended and the vaccines be recalled as there has been no scientific basis to allow their administration.
“The two companies have also flouted Indian law with impunity and have not done the post marketing studies ordered by the Drugs Controller at the time of licensing.
“They have not up dated their product information and hence the Indian medical consumer continues to be in the dark about hazards of these vaccines that contain insect cells. MSD Pharmaceuticals went a step further and got the eligible age group extended to 45 year old women in India though this was denied in the US thrice,” the petitioner said.