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 Monsoon Session of Parliament begins tomorrow and will continue till August 10, 2018. It is scheduled to have 18 sittings during this period. This post outlines what is in store in the upcoming session.
The session has a packed legislative agenda. Presently, there are 68 Bills pending in Parliament. Of these, 25 have been listed for consideration and passage. In addition, 18 new Bills have been listed for introduction, consideration, and passage. This implies that Parliament has the task of discussing and deliberating 43 Bills listed for passage in an 18-day sitting period. Key among them include the Bills that are going to replace the six Ordinances currently in force. The government is going to prioritize the passage of these six Bills to ensure that the Ordinances do not lapse.
Besides the heavy legislative agenda, the session will also witness the election of a new Deputy Chairman for the Upper House. Former Deputy Chairman, P.J. Kurien’s term ended on July 1, 2018. The upcoming election has generated keen interest, and will be closely watched. The role of the Deputy Chairman is significant, as he quite frequently oversees the proceedings of the House. The Deputy Chairman is responsible for maintaining order in the house and ensuring its smooth functioning. The preceding Budget Session was the least productive since 2000 due to disruptions. Rajya Sabha spent only 2 hours and 31 minutes discussing legislative business, of which 3 minutes were spent on government Bills. In this context, the role of the Deputy Chairman is important in ensuring productivity of the house.
Another key player in ensuring productivity of Parliament is the Speaker of the Lower House. In Budget Session 2018, the Speaker was unable to admit a no confidence motion. This failure was based on her inability to bring the house in order. Repeated disruptions led to the passage of only two Bills in Lok Sabha. The same session also saw disruptions by certain MPs demanding special category status for Andhra Pradesh. Between the last session and the upcoming session, a key development includes the resignation of five YRSC members, reducing the strength of MPs from Andhra Pradesh to 20. In light of this, one has to wait to see whether the demand for special category status for Andhra Pradesh will be raised again.
Coming to the legislative agenda, of the six Bills that aim to replace Ordinances, key include: (i) the Fugitive Economic Offenders Bill, 2018, (ii) the Criminal Law (Amendment) Bill, 2018, (iii) the Insolvency and Bankruptcy Code (Amendment) Bill, 2018, and (iv) the Commercial Courts (Amendment) Bill, 2018. The Fugitive Economic Offenders Bill aims to confiscate the properties of people who have absconded the country in order to avoid facing prosecution for economic offences. The Fugitive Economic Offenders Bill, 2018 was introduced in Lok Sabha in March 2018. Subsequently, an Ordinance was promulgated on April 21, 2018. The Criminal Law (Amendment) Bill increases the punishment for rape of women, and introduces death penalty for rape of minor girls below the age of 12. The Insolvency and Bankruptcy (Amendment) Bill aims to address existing challenges in the Insolvency and Bankruptcy Code. It amends the Code to include homebuyers as financial creditors in the insolvency resolution process.
There are some Bills that have been passed by one house but are pending in the other, and some that are pending in both the houses. These cut across various sectors, including social reform, education, health, consumer affairs, and transport. Some key reformative legislation currently pending include the Transgender Persons (Protection of Rights) Bill, 2016, and the Triple Talaq Bill. The Triple Talaq Bill, passed on the day of introduction in Lok Sabha, is pending in Rajya Sabha. When introduced in Rajya Sabha, the opposition introduced a motion to refer the Bill to a Select Committee. In the forthcoming session, it remains to be seen whether the Bill will be sent to a Select Committee for detailed scrutiny or will be passed without reference to a Committee. Other pending legislation include the the National Medical Commission Bill, 2017, the RTE (Second Amendment) Bill, 2017, the Consumer Protection Bill, 2018 and the Specific Relief (Amendment) Bill, 2017.
Of the 18 new Bills listed for introduction, all have been listed for consideration and passage as well. These include the Trafficking of Persons Bill, 2018, the DNA Technology (Use and Application) Regulation Bill, and amendments to the RTI Act. Since they have been listed for passage, it remains to be seen whether these Bills are scheduled to be scrutinized by a Parliamentary Committee. In the 16th Lok Sabha, only 28% of the Bills introduced in Lok Sabha have been referred to Committees. This number is low in comparison to 60% and 71% of the introduced Bills being referred to Committees in the 14th and 15th Lok Sabha, respectively. Committees ensure that Bills are closely examined. This facilitates informed deliberation on the Bill, and strengthens the legislative process.
Besides taking up the legislative agenda, an important function of Parliament is to discuss issues of national importance and hold the government accountable. In the previous session, the issue of irregularities in the banking sector was repeatedly listed for discussion. However, due to disruptions, it was not taken up. Budget Session 2018 saw the lowest number of non- legislative debates since the beginning of the 16th Lok Sabha. In the upcoming session, it is likely that members will raise various issues for discussion. It remains to be seen whether Parliament will function smoothly in order to power through its agenda, and fulfil its obligation to hold the government accountable.
