Aastha Mehta, Student of Law, GNLU, Gandhinagar
Supreme Court has again taken favored stand for the citizens of the country, by criticizing the Government for not having any framework of rules for clinical trials in India. In a PIL filed by NGO Swasthya Adhikar Manch, the apex Court has directed the government that no clinical trials of untested drugs usually tested on volunteers and patients will be conducted till regulatory legislation or set of rules are in place. The direction has come as shock for pharmaceutical multinational companies however the Court said that lives of the citizens of this country cannot be played with.
The act in question was Drugs and Cosmetics Act, as amended on 2008, which is piecemeal legislation when it comes to use of medicines, antibiotics along with sale and licensing of such drugs and cosmetics. The Additional Solicitor General had argued in the instant case that Union Ministry for Health is considering some serious changes in the Act to make sure that clinical trials are covered within the ambit of this Act, by making a separate chapter on this topic. However the underlying point in the said order of SC shows how concerned and obliged the courts in our country feel when it comes to the question of human life. On seeing the statistics filed by the Centre in their affidavit the Centre admitted to the fact that 2,644 people died during clinical trials of 475 new drugs from the period 2005 to 2012. Though the government kept on saving itself by showing the court various notifications whereby they showed that the proposed amendments also had envisaged process of carrying inspections of clinical trials by setting up an authority especially for the purpose along with a mechanism in place to analyze the reports of Serious Adverse Events happening due to unregulated clinical trials of new medicines on people. But the court turned a deaf ear to all the contingent regulations and specifically banned 162 trials being undertaken by the government till something concrete was done.
Right to Life as enshrined in Article 21 of Indian Constitution has its shadow in this order, and which has made the Court take the morally correct stand, since the it would have been easy for courts to give in to the pressures of big companies which have vested interest in not having any mechanism to keep clinical trials in check. But court has been firm in pronouncing down from the very first, that Article 21 is a wide enough to cover all aspects which will ensure that a human beings live their life with dignity and respect. In future, it is left to be seen how such protective and pro-justice attitude of the apex court translates from mere copy of judgment to real ground practice.