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 Damage for Nuclear Liability Bill, 2010 has been criticised on many grounds (Also click here), including (a) capping liability for the operator, (b) fixing a low cap on the amount of liability of the operator, and (c) making the operator solely liable. We summarise the main principles of civil nuclear liability mentioned in IAEA's Handbook on Nuclear Law: Strict Liability of the Operator: The operator is held liable regardless of fault. Those claiming compensation do not need to prove negligence or any other type of fault on the part of the operator. The operator is liable merely by virtue of the fact that damage has been caused. Legal channeling of liability on the operator: "The operator of a nuclear installation is exclusively liable for nuclear damage. No other person may be held liable, and the operator cannot be held liable under other legal provisions (e.g. tort law)...This concept is a feature of nuclear liability law unmatched in other fields of law." The reason for this has been quoted in the Handbook as:
"...Firstly, it is desirable to avoid difficult and lengthy questions of complicated legal cross-actions to establish in individual cases who is legally liable. Secondly, such channelling obviates the necessity for all those who might be associated with construction or operation of a nuclear installation other than the operator himself to take out insurance also, and thus allows a concentration of the insurance capacity available.”
Limiting the amount of liability: "Limitation of liability in amount is clearly an advantage for the operator. Legislators feel that unlimited liability, or very high liability amounts, would discourage people from engaging in nuclear related activities. Operators should not be exposed to financial burdens that could entail immediate bankruptcy....Whatever figure is established by the legislator will seem to be arbitrary, but, in the event of a nuclear catastrophe, the State will inevitably step in and pay additional compensation. Civil law is not designed to cope with catastrophes; these require special measures." Limitation of liability in time: "In all legal systems there is a time limit for the submission of claims. In many States the normal time limit in general tort law is 30 years. Claims for compensation for nuclear damage must be submitted within 30 years in the event of personal injury and within 10 years in the event of other damage. The 30 year period in the event of personal injury is due to the fact that radiation damage may be latent for a long time; other damage should be evident within the 10 year period." Insurance coverage: "The nuclear liability conventions require that the operator maintain insurance or provide other financial security covering its liability for nuclear damage in such amount, of such type and in such terms as the Installation State specifies....This ensures that the liability amount of the operator is always covered by an equal amount of money. The congruence principle is to the advantage both of the victims of a nuclear incident and of the operator. The victims have the assurance that their claims are financially covered, and the operator has funds available for compensation and does not need to convert assets into cash.
