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:
On September 14, 2012 the government announced a new FDI policy for the broadcasting sector. Under the policy, FDI up to 74% has been allowed in broadcasting infrastructure services. Previously the maximum level of FDI permitted in most infrastructure services in the sector was 49% through automatic route. There could be three reasons for the increase in FDI in the sector. First, the broadcasting sector is moving towards an addressable (digital) network. As per Telecom Regulatory Authority of India (TRAI), this upgradation could cost Rs 40,000 crore. Second, the increase in FDI was mandated because a higher FDI was allowed for telecommunication services, which too are utilised for broadcast purposes. In telecommunications 74% FDI is allowed under the approval route. Third, within the broadcasting sector, there was disparity in FDI allowed on the basis of the mode of delivery. These issues were referred to by TRAI in detail in its recommendations of 2008 and 2010. Recent history of FDI in broadcasting services In 2008 and 2010 TRAI had recommended an increase in the level of FDI permitted. A comparison of recommendations and the new policy is provided below. 
As noted in the table, FDI in services that relate to establishing infrastructure, like setting up transmission hubs and providing services to the customers, is now at 49% under automatic route and 74% with government approval. FDI in media houses, on the other hand, have a different level of FDI permitted. TRAI’s recommendations on the two aspects of FDI in broadcasting Digitisation of cable television network: The Cable Televisions Networks Act, 1995 was amended in 2011 to require cable television networks to be digitised. By October 31, 2012 all cable subscriptions in Delhi, Mumbai, Chennai and Kolkata are required to be digitised. The time frame for digitisation for the entire country is December 31, 2014. However, this requires investment to establish infrastructure. As per the TRAI 2010 report, there are a large number of multi-system operators (who receive broadcasting signals and transmit them further to the cable operator or on their own). As per the regulator, this has led to increased fragmentation of the industry, sub-optimal funding and poor services. Smaller cable operators do not have the resources to provide set-top boxes and enjoy economies of scale. As per news reports, the announcement of higher FDI permission would enable the TV distribution industry to meet the October 31 deadline for mandatory digitisation in the four metros. Diversity in television services: FDI in transmitting signals from India to a satellite hub for further transmission (up-linking services) has not been changed. This varies on the basis of the nature of the channel. For non-news channels, FDI up to 100% with government approval was allowed even under the previous policy. However, the FDI limit for news channels is 26% with government approval. In 2008 TRAI had recommended that this be increased to 49%. However, it reviewed its position in 2010. It argued that since FM and up-linking of news channels had the ability to influence the public, the existing FDI level of 26% was acceptable. It also relied upon the level of FDI permitted in the press, stating that parity had to be maintained between the two modes of broadcast. Under the new policy the level of FDI permitted in these sectors has not been changed.
