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:
Last week, the Assam Legislative Assembly passed the Assam Cattle Preservation Bill, 2021. The Bill seeks to regulate the slaughter and transportation of cattle and the sale of beef. It replaces the Assam Cattle Preservation Act, 1950, which only provided for restrictions on cattle slaughter. In this post, we examine the Bill and compare it with other state laws on cattle preservation. For a detailed analysis of the Bill, see here.
Cattle preservation under the Bill
The Bill prohibits the slaughter of cows of all ages. Bulls and bullocks, on the other hand, may be slaughtered if they are: (i) over 14 years of age, or (ii) permanently incapacitated due to accidental injury or deformity. Inter-state and intra-state transport of cattle is allowed only for agricultural or animal husbandry purposes. This requires a permit from the competent authority (to be appointed by the state government). Further, the Bill allows the sale of beef and beef products only at certain locations as permitted by the competent authority. No permission for such sale will be granted in areas that are predominantly inhabited by Hindu, Jain, Sikh and other non-beef eating communities, or within a five-kilometre radius of a temple or other Hindu religious institution.
Provisions of the Bill may raise certain issues which we discuss below.
Undue restriction on cattle transport in the north-eastern region of India
The Bill prohibits the transport of cattle from one state to another (or another country) through Assam, except with a permit that such transport is for agricultural or animal husbandry purposes. This may lead to difficulties in movement of cattle to the entire north-eastern region of India. First, the unique geographical location of Assam makes it an unavoidable transit state when moving goods to other north-eastern states. Second, it is unclear why Assam may disallow transit through it for any purposes other than agriculture or animal husbandry that are allowed in the origin and destination states. Note that the Madhya Pradesh Govansh Vadh Pratishedh Adhiniyam, 2004 provides for a separate permit called a transit permit for transporting cattle through the state. Such permit is for the act of transport, without any conditions as to the purpose of transport.
Unrestricted outward transport of cattle to states that regulate slaughter differently from Assam
The Bill restricts the transport of cattle from Assam to any place outside Assam “where slaughter of cattle is not regulated by law”. This implies that cattle may be transported without any restrictions to places outside Assam where cattle slaughter is regulated by law. It is unclear whether this seeks to cover any kind of regulation of cattle slaughter, or only regulation that is similar to the regulation under this Bill. The rationale for restricting inter-state transport may be to pre-empt the possibility of cattle protected under the Bill being taken to other states for slaughter. If that is the intention, it is not clear why the Bill exempts states with any regulation for cattle slaughter from transport restrictions. Other states may not have similar restrictions on cattle slaughter as in the Bill. Note that other states such as Karnataka and Chhattisgarh restrict outgoing cattle transport without making any distinction between states that regulate cattle slaughter and those that do not.
Effective prohibition on sale of beef in Assam
The Bill prohibits the sale of beef within a five-kilometre radius of a temple (which means an area of about 78.5 square kilometres around a temple). This threshold may be overly restrictive. As per the 2011 census, the average town area in Assam is 5.89 square kilometres (sq km) and the average village area is 1.93 sq km. The three largest towns of Assam by area are: (i) Guwahati (219.1 sq km), (ii) Jorhat (53.5 sq km), and (iii) Dibrugarh (20.8 sq km). Hence, even if there is only one temple in the middle of a town, no town in Assam – except Guwahati – can have a beef shop within the town area. Similarly, if a village has even one temple, a beef shop cannot be set up in a large area encompassing several adjoining villages as well. In this manner, the Bill may end up completely prohibiting sale of beef in the entire state, instead of restricting it to certain places.
Note that certain states such as Gujarat, Rajasthan, Uttar Pradesh and Haryana completely prohibit the sale or purchase of beef within the state. However, they also completely prohibit the slaughter of cows, bulls and bullocks. This is not the case under the Bill, which only places a complete prohibition on slaughter of cows. Further, in places such as Delhi, municipal regulations prohibit the sale of meat (including beef) within 150 metres from a temple or other religious place. This minimum distance requirement does not apply at the time of renewal of license for selling meat if the religious place comes into existence after the grant of such license.
The prohibition on sale of beef in areas predominantly inhabited by communities identified based on religion or food habits (non-beef eating) may also have an unintended consequence. With the food typically consumed by a community becoming unavailable or available only in select locations, it may lead to the segregation of different communities into demarcated residential areas. As per the 2011 census, the population of Assam comprises roughly 61% Hindus, 34% Muslims, and 4% Christians.
Onerous requirement for the accused to pay maintenance cost of seized cattle
Cattle rearing is essentially an economic activity. Under the Bill, cattle may be seized by a police officer on the basis of suspicion that an offence has been or may be committed. Seized cattle may be handed over to a care institution, and the cost of its maintenance during trial will be recovered from such persons as prescribed by the state government through rules. Note that there is no time frame for completing a trial under the Bill. Thus, if the owner or transporter of seized cattle is made liable to pay its maintenance cost, they may be deprived of their source of livelihood for an indefinite period while at the same time incurring a cost.
Cattle preservation laws in other states
The Directive Principles of State Policy under the Constitution call upon the state to prohibit the slaughter of cows, calves, and other milch and draught cattle. Currently, more than 20 states have laws restricting the slaughter of cattle (cows, bulls, and bullocks) and buffaloes to various degrees. Table 1 below shows a comparison of such laws in select states of India. Notably, north-eastern states such as Arunachal Pradesh, Meghalaya, Mizoram and Nagaland do not have any law regulating cattle slaughter.
