The Parliamentary Standing Committee on Health and Family Welfare tabled a Report in Parliament on May 8, 2012, on the functioning of the Central Drugs Standard Control Organization (CDSCO). CDSCO is the agency mandated with the regulation of drugs and cosmetics in India. The Report covers various aspects of drug regulation including organizational structure and strength of CDSCO, approval of new drugs, and banning of drugs, among others. Following the Report, the Minister of Health and Family Welfare has constituted a Committee to look into the procedure for drug regulation. The Committee is expected to make its submissions within a period of two months. This post focuses on irregularities in the approval of new drugs by CDSCO. It discusses the regulations relating to drug approval and the Standing Committee's observations on the working of CDSCO. Approval of new drugs Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945 [Rules]. The CDSCO, under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import. State Drug Authorities are the licensing authorities for marketing drugs. New Drugs are defined as:
The Rules require an applicant for a new drug to conduct clinical trials in India to determine the drug’s safety and efficacy. These trials are necessary for both domestically manufactured and imported drugs. However, the authority can exempt a drug from the requirement of local and clinical trials in the public interest based on data available in other countries. Observations and recommendations of the Committee The Committee found that a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients. The Report mentioned that drug manufacturers, CDSCO officials and medical experts colluded to approve drugs in violation of laws. Following are some of the Report’s findings:
A Bill to amend the Lokpal and Lokayuktas Act, 2013 was introduced and passed in Lok Sabha yesterday. The Bill makes amendments in relation to the declaration of assets of public servants, and will apply retrospectively. Declaration of assets under the Lokpal Act, 2013 The Lokpal Act, 2013 provides for a mechanism to inquire into corruption related allegations against public servants. The Act defines public servants to include the Prime Minister, Union Ministers, Members of Parliament, central government and Public Sector Undertakings employees, and trustees and officials of NGOs that receive foreign contribution above Rs 10 lakhs a year, and those getting a certain amount of government funding. [A June 2016 notification set this amount at Rs. 1 crore.] The Lokpal Act mandates public servants to declare their assets and liabilities, and that of their spouses and dependent children. Such declarations must be filed by July 31st every year. They must also be published on the website of the Ministry by August 31st. 2014 amendments proposed to the Lokpal Act In December 2014, a Bill to amend the 2013 Act was introduced in Lok Sabha. Among other things, the Bill sought to modify the provision related to declaration of assets by public servants. The Bill required that the public servant’s declaration contain information of all his assets, including: (i) movable and immovable property owned, inherited, acquired, or held on lease in his or another’s name; and (ii) debts and liabilities incurred directly or indirectly by him. The Bill also said that declaration requirements for public servants under the Representation of the People Act, 1951 (for MPs), All India Services Act, 1951 (for senior civil servants), etc. would also apply. The Standing Committee that examined this Bill, in 2015, had recommended that the public servants should declare the assets and liabilities to their Competent Authority. For example, for an MP, the competent authority would be the Speaker of Lok Sabha or Chairman of Rajya Sabha. Such declarations should then be forwarded to the Lokpal to keep in a fiduciary capacity. Both these authorities would be competent to review the returns filed by the public servants. In light of such double scrutiny, the Committee recommended that public disclosure of such assets and liabilities would not be necessary. Further, the Committee also noted that family members of public servants are not obliged to disclose assets acquired through their own income. These disclosures may be in violation of Article 21 (right to privacy) or 14 (right to equality) of the Constitution. However, the public servant must declare assets and liabilities of his dependents, and those acquired by him in the name of another. This Bill is currently pending in Lok Sabha. The 2016 Bill and its position on declaration of assets The Amendment Bill, that was introduced and passed by Lok Sabha yesterday, replaces the provision under the Lokpal Act, 2013 related to the declaration of assets and liabilities by public servants. While the new provision also mandates public servants to declare their assets and liabilities, it does not specify the manner of such declaration. The Bill states that the form and manner of such declarations to be made by public servants will be prescribed by the central government. Therefore, if passed by Parliament, the effect of the amendments will be the following:
These implications will apply only if the Bill is passed by Rajya Sabha and gets the President’s assent before July 31, 2016.
