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:
Recently, the Parliament passed a law that addresses the issue of sexual harassment in the work place. The Bill, introduced in the Lok Sabha on December 7, 2010, drew on the 1997 judgment of the Supreme Court (known as the Vishaka judgment) to codify measures that employers need to take to address sexual harassment at the work place. (See PRS analysis of the Bill here). The Bill was first passed in the Lok Sabha on September 3, 2011. It incorporated many of the amendments recommended by the Standing Committee on Human Resource Development that examined the Bill. The Rajya Sabha passed it on February 27, 2013 without any new amendments (see Bill as passed by Parliament). We compare the key provisions of the Bill, the Standing Committee recommendations and the Bill that was passed by Parliament (for a detailed comparison, see here).
| Bill as introduced | Standing Committee recommendations | Bill as passed by Parliament |
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Clause 2: Status of domestic workers |
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| Excludes domestic workers from the protection of the Bill. | The definition should include (i) domestic workers; and (ii) situations involving ‘victimization’; | Includes domestic worker. Does not include victimisation. |
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Clause 4: Constitution of Internal Complaints Committee (ICC) |
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| The committee shall include 4 members: a senior woman employee, two or more employees and one member from an NGO committed to the cause of women. | The strength of ICC should be increased from 4 to at least 5 (or an odd number) to facilitate decisions in cases where the bench is divided. | Disqualifies a member if (a) he has been convicted of an offence or an inquiry is pending against him or (b) he is found guilty in disciplinary proceedings or a disciplinary proceeding is pending against him. |
| Members may not engage in any paid employment outside the office. | Barring paid employment outside the office goes against NGO members who may be employed elsewhere. This clause must be edited. | Deletes the provision that disallows NGO members to engage in paid employment outside. NGO members to be paid fees or allowances. |
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Clause 6: Constitution and jurisdiction of Local Complaints Committee (LCC) |
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| An LCC is required to be constituted in every district and additional LLCs at block level. At the block level the additional LCC will address complaints where the complainant does not have recourse to an ICC or where the complaint is against the employer. | The functions of the district level and the block level LCCs are not delineated clearly. It is also unclear whether the block level LCCs are temporary committees constituted for dealing with specific cases. Instead of creating additional LCCs at the block level, the District level LCC may be allowed to handle cases. A local member from the block may be co-opted as a member to aid the LCC in its task. | Accepted. |
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Clause 10: Conciliation |
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| The ICC/ LCC shall provide for conciliation if requested by the complainant. Otherwise, it shall initiate an inquiry. | Distinction should be made between minor and major offences. Conciliation should be allowed only for minor offences. | Adds a proviso that monetary settlement shall not be the basis on which conciliation is made. |
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Clause 11: Inquiry into Complaint |
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| ICC/LCC shall proceed to make inquiry into a complaint in such manner as may be prescribed. | No suggestion. | Inquiries will be conducted in accordance with service rules or in such manner as may be prescribed.For domestic workers, the LCC shall forward the complaint to the police within seven days if a prima facie case exists. The case shall be registered under section 509 of Indian Penal Code (word, gesture or act intended to insult the modesty of a woman). |
| Sources: The Protection of Women Against Sexual Harassment at Work Place Bill, 2010; the Standing Committee on HRD Report on the Bill; the Sexual Harassment at Work Place (Prevention, Prohibition and Redressal) Bill, 2012; PRS. | ||
