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:
In law, the addition or deletion a single punctuation or a single word can have a major impact on the effect of that law. One such example can be seen from the recommended changes in the Civil Liability for Nuclear Damage Bill, 2010 by Parliament’s Standing Committee. The Civil Liability for Nuclear Damage Bill, 2010 was introduced in the Lok Sabha on May 7, 2010. The Bill was referred to the Parliamentary Committee on Science and Technology, Environment and Forests, which submitted its report on the Bill yesterday (August 18, 2010). The Committee has made a number of recommendations regarding certain clauses in the Bill (See summary here). One of these may have the effect of diluting the provision currently in the Bill. The main recommendations pertain to:
Clause 17 of the Bill which gives operators a right of recourse against those actually causing damage had been opposed as it was felt that it was not strong enough to hold suppliers liable in case the damage was caused by them. Clause 17 gave a right of recourse under three conditions. The exact clause is reproduced below: The operator of a nuclear installation shall have a right of recourse where — (a) such right is expressly provided for in a contract in writing; (b) the nuclear incident has resulted from the wilful act or gross negligence on the part of the supplier of the material, equipment or services, or of his employee; (c) the nuclear incident has resulted from the act of commission or omission of a person done with the intent to cause nuclear damage. Under this clause, a right of recourse exists when (a) there is a contract giving such a right, or (b) the supplier acts deliberately or in a grossly negligent manner to cause nuclear damage, or (c) a person causes nuclear damage with the intent to do so. If any of the three cases can be proved by the operator, he has a right of recourse. The Committee has stated that “Clause 17(b) gives escape route to the suppliers of nuclear materials, equipments, services of his employees as their willful act or gross negligence would be difficult to establish in a civil nuclear compensation case.” It recommended that Clause 17(b) should be modified to cover consequences “of latent or patent defect, supply of sub-standard material, defective equipment or services or from the gross negligence on the part of the supplier of the material, equipment or service.” The Committee also recommended another change in Clause 17. It recommended that clause 17(a) may end with “and”. This provision may dilute the right of recourse available to operators. The modified clause 17 would read as: The operator of a nuclear installation shall have a right of recourse where — (a) such right is expressly provided for in a contract in writing; and, (b) the nuclear incident has resulted as a consequence of latent or patent defect, supply of sub-standard material, defective equipment or services or from the gross negligence on the part of the supplier of the material, equipment or services.; (c) the nuclear incident has resulted from the act of commission or omission of a person done with the intent to cause nuclear damage. This implies that for Clauses 17(b) or (c) to be applicable, the condition specified in clause 17(a) has to be compulsorily satisfied. Two examples highlight the consequence of the recommended change in Clause 17(a) of the Bill:
The effect of the changes recommended by the committee may thus dilute the provision as it exists in the Bill. The table below compares the position in the Bill and the position as per the Standing Committee’s recommendations:
| Right of recourse - The Bill gives operators a right to recourse under three conditions: (a) if there is a clear contract; (b) if the damage is caused by someone with intent to cause damage; (c) against suppliers if damage is caused by their wilful act or negligence. | In the Bill the three conditions are separated by a semi-colon. The Committee recommended that the semi-colon in clause 17(a) should be replaced by “and”. | This might imply that all three conditions mentioned need to exist for an operator to have recourse. |
| Right to recourse against suppliers exists in cases of “willful act or gross negligence on the part of the supplier”. (Clause 17) | The Committee felt that the right of recourse against suppliers is vague. It recommended that recourse against the supplier should be strengthened. The supplier is liable if an incident has occurred due to (i) defects, or (ii) sub-standard material, or (iii) gross negligence of the supplier of the material, equipment or services. | The variance with the Convention continues to exist. |
