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:
A few minutes ago, the Supreme Court delivered a judgement striking down Section 66 A of the Information Technology Act, 2000. This was in response to a PIL that challenged the constitutionality of this provision. In light of this, we present a background to Section 66 A and the recent developments leading up to its challenge before the Court. What does the Information Technology Act, 2000 provide for? The Information Technology (IT) Act, 2000 provides for legal recognition for transactions through electronic communication, also known as e-commerce. The Act also penalizes various forms of cyber crime. The Act was amended in 2009 to insert a new section, Section 66A which was said to address cases of cyber crime with the advent of technology and the internet. What does Section 66(A) of the IT Act say? Section 66(A) of the Act criminalises the sending of offensive messages through a computer or other communication devices. Under this provision, any person who by means of a computer or communication device sends any information that is:
Over the past few years, incidents related to comments, sharing of information, or thoughts expressed by an individual to a wider audience on the internet have attracted criminal penalties under Section 66(A). This has led to discussion and debate on the ambit of the Section and its applicability to such actions. What have been the major developments in context of this Section? In the recent past, a few arrests were made under Section 66(A) on the basis of social media posts directed at notable personalities, including politicians. These were alleged to be offensive in nature. In November 2012, there were various reports of alleged misuse of the law, and the penalties imposed were said to be disproportionate to the offence. Thereafter, a Public Interest Litigation (PIL) was filed in the Supreme Court, challenging this provision on grounds of unconstitutionality. It was said to impinge upon the freedom of speech and expression guaranteed by Article 19(1)(a) of the Constitution. How has the government responded so far? Subsequently, the central government issued guidelines for the purposes of Section 66(A). These guidelines clarified that prior approval of the Deputy Commissioner or Inspector General of Police was required before a police officer or police station could register a complaint under Section 66(A). In May 2013, the Supreme Court (in relation to the above PIL) also passed an order saying that such approval was necessary before any arrest is to be made. Since matters related to police and public order are dealt with by respective state governments, a Supreme Court order was required for these guidelines to be applicable across the country. However, no changes have been made to Section 66 A itself. Has there been any legislative movement with regard to Section 66(A)? A Private Member Bill was introduced in Lok Sabha in 2013 to amend Section 66(A) of the IT Act. The Statement of Objects and Reasons of the Bill stated that most of the offences that Section 66(A) dealt with were already covered by the Indian Penal Code (IPC), 1860. This had resulted in dual penalties for the same offence. According to the Bill, there were also inconsistencies between the two laws in relation to the duration of imprisonment for the same offence. The offence of threatening someone with injury through email attracts imprisonment of two years under the IPC and three years under the IT Act. The Bill was eventually withdrawn. In the same year, a Private Members resolution was also moved in Parliament. The resolution proposed to make four changes: (i) bring Section 66(A) in line with the Fundamental Rights of the Constitution; (ii) restrict the application of the provision to communication between two persons; (iii) precisely define the offence covered; and (iv) reduce the penalty and make the offence a non-cognizable one (which means no arrest could be made without a court order). However, the resolution was also withdrawn. Meanwhile, how has the PIL proceeded? According to news reports, the Supreme Court in February, 2015 had stated that the constitutional validity of the provision would be tested, in relation to the PIL before it. The government argued that they were open to amend/change the provision as the intention was not to suppress freedom of speech and expression, but only deal with cyber crime. The issues being examined by the Court relate to the powers of the police to decide what is abusive, causes annoyance, etc,. instead of the examination of the offence by the judiciary . This is pertinent because this offence is a cognizable one, attracting a penalty of at least three years imprisonment. The law is also said to be ambiguous on the issue of what would constitute information that is “grossly offensive,” as no guidelines have been provided for the same. This lack of clarity could lead to increased litigation. The judgement is not available in the public domain yet. It remains to be seen on what the reasoning of the Supreme Court was, in its decision to strike down Section 66A, today.
