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:
The Civil Liability for Nuclear Damage Bill, 2010 was introduced in the Lok Sabha on may 7, 2010. The following is PRS’s summary of the Bill (The Bill summary and the Bill along with related media articles can also be accessed on the PRS Website):
The main features of the Bill are:
a. It defines nuclear incidents and nuclear damage, nuclear fuel, material and nuclear installations, and also operators of nuclear installations.
b. It lays down who will be liable for nuclear damage, and the financial limit of the liability for a nuclear incident.
c. It creates authorities who will assess claims and distribute compensation in cases of nuclear damage. It also specifies who can claim compensation for nuclear damage, and how compensation can be claimed and distributed.
d. It specifies penalties for not complying with the provisions of the Bill, or any directions issued under it.
Nuclear damage means (a) loss of life or injury to a person, or loss of, or damage to property caused by a nuclear incident (b) economic loss arising out of such damage to person or property, (c) costs of measures to repair the damage caused to the environment, and (d) costs of preventive measures.
The Atomic Energy Regulatory Board has to notify a nuclear incident within 15 days from the date of a nuclear incident occurring.
The operator of a nuclear installation will be liable for nuclear damage caused by a nuclear incident in that installation or if he is in charge of nuclear material. If more than one operator is liable for nuclear damage, all operators shall be jointly, and also individually liable to pay compensation for the damage. The Bill also provides certain exceptions to an operator’s liability.
The operator has a right of recourse against the supplier and other individuals responsible for the damage under certain conditions.
The Bill states that the total liability for a nuclear incident shall not exceed 300 million Special Drawing Rights (Approximately Rs 2100 crore at current exchange rates).
Within this amount, the liability of the operator shall be Rs 500 crore. If the liability exceeds Rs 500 crore, the central government shall be liable for the amount exceeding Rs 500 crore (up to SDR 300 million). If damage is caused in a nuclear installation owned by the central government, the government will be solely liable.
The Bill allows the central government to create two authorities by notification:
a. Claims Commissioner: The Claims Commissioner will have certain powers of a civil court. Once a nuclear incident is notified, the Commissioner will invite applications for claiming compensation.
b. Nuclear Damage Claims Commission: If the central government thinks that with regard to a nuclear incident (a) the amount of compensation may exceed Rs 500 crore, or (b) it is necessary that claims will be heard by the Commission and not the Claims Commissioner, or (c) that it is in public interest, it can establish a Nuclear Damage Claims Commission. The Commission shall have the same powers as that of a Claims Commissioner.
An application for claiming compensation can be made by (a) person sustaining the injury, (b) owner of the damaged property, (c) legal representative of a deceased person, or (d) an authorised agent. An application can be made within three years from the date of the person having knowledge of nuclear damage. This right to make an application is however exhausted after a period of ten years from the date of the notification of the nuclear incident.
he Civil Liability for Nuclear Damage Bill, 2010 was introduced in the Lok Sabha on May 7, 2010. The main features of the Bill are:
a. It defines nuclear incidents and nuclear damage, nuclear fuel, material and nuclear installations, and also operators of nuclear installations.
b. It lays down who will be liable for nuclear damage, and the financial limit of the liability for a nuclear incident.
c. It creates authorities who will assess claims and distribute compensation in cases of nuclear damage. It also specifies who can claim compensation for nuclear damage, and how compensation can be claimed and distributed.
d. It specifies penalties for not complying with the provisions of the Bill, or any directions issued under it.
§ Nuclear damage means (a) loss of life or injury to a person, or loss of, or damage to property caused by a nuclear incident (b) economic loss arising out of such damage to person or property, (c) costs of measures to repair the damage caused to the environment, and (d) costs of preventive measures.
§ The Atomic Energy Regulatory Board has to notify a nuclear incident within 15 days from the date of a nuclear incident occurring.
§ The operator of a nuclear installation will be liable for nuclear damage caused by a nuclear incident in that installation or if he is in charge of nuclear material. If more than one operator is liable for nuclear damage, all operators shall be jointly, and also individually liable to pay compensation for the damage. The Bill also provides certain exceptions to an operator’s liability.
§ The operator has a right of recourse against the supplier and other individuals responsible for the damage under certain conditions.
§ The Bill states that the total liability for a nuclear incident shall not exceed 300 million Special Drawing Rights (Approximately Rs 2100 crore at current exchange rates).
§ Within this amount, the liability of the operator shall be Rs 500 crore. If the liability exceeds Rs 500 crore, the central government shall be liable for the amount exceeding Rs 500 crore (up to SDR 300 million). If damage is caused in a nuclear installation owned by the central government, the government will be solely liable.
§ The Bill allows the central government to create two authorities by notification:
a. Claims Commissioner: The Claims Commissioner will have certain powers of a civil court. Once a nuclear incident is notified, the Commissioner will invite applications for claiming compensation.
b. Nuclear Damage Claims Commission: If the central government thinks that with regard to a nuclear incident (a) the amount of compensation may exceed Rs 500 crore, or (b) it is necessary that claims will be heard by the Commission and not the Claims Commissioner, or (c) that it is in public interest, it can establish a Nuclear Damage Claims Commission. The Commission shall have the same powers as that of a Claims Commissioner.
An application for claiming compensation can be made by (a) person sustaining the injury, (b) owner of the damaged property, (c) legal representative of a deceased person, or (d) an authorised agent. An application can be made within three years from the date of the person having knowledge of nuclear damage. This right to make an application is however exhausted after a period of ten years from the date of the notification of the nuclear incident.
