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:

  • drugs that have not been used in the country before,
  • drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
  • fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.

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:

  • Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample.  This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity.  The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.
  •  The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India.  A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data.  Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers.  The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.
  •  The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin.  CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin.  Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials.  The Committee recommended an inquiry into the unlawful approval of these drugs.
  • The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age.  CDSCO violated this rule in approving Letrozole for treating female infertility.  Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women.  The drug has not been permitted for use among women of reproductive age because of side effects.  The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.
  •  Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO.  PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences.  When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs.  The Report contended that this action reflected a poor follow-up of side effects on Indian patients.  The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.

Yesterday, the Telecom and Regulatory Authority of India (TRAI) released the Prohibition of Discriminatory Tariffs for Data Services Regulations, 2016.  These regulations prohibit Telecom Service Providers from charging different tariffs from consumers for accessing different services online.  A lot of debate has taken place around network (net) neutrality in India, in the past few months.  This blog post seeks to present an overview of the developments around net neutrality in India, and perspectives of various stakeholders. Who are the different stakeholders in the internet space? To understand the concept of net neutrality, it is important to note the four different kinds of stakeholders in the internet space that may be affected by the issue.  They are: (i) the consumers of any internet service, (ii) the Telecom Service Providers (TSPs) or Internet Service Providers (ISPs), (iii) the over-the-top (OTT) service providers (those who provide internet access services such as websites and applications), and (iv) the government, who may regulate and define relationships between these players.  TRAI is an independent regulator in the telecom sector, which mainly regulates TSPs and their licensing conditions, etc., What is net neutrality? The principle of net neutrality states that internet users should be able to access all content on the internet without being discriminated by TSPs.  This means that (i) all websites or applications should be treated equally by TSPs, (ii) all applications should be allowed to be accessed at the same internet speed, and (iii) all applications should be accessible for the same cost.  The 2016 regulations that TRAI has released largely deal with the third aspect of net neutrality, relating to cost. What are OTT services? OTT services and applications are basically online content.  These are accessible over the internet and made available on the network offered by TSPs.  OTT providers may be hosted by TSPs or ISPs such as Bharti Airtel, Vodafone, Idea, VSNL (government provided), etc.  They offer internet access services such as Skype, Viber, WhatsApp, Facebook, Google and so on.  Therefore, OTT services can broadly be of three types: (i) e-commerce, (ii) video or music streaming and, (iii) voice over internet telephony/protocol services (or VoIP communication services that allow calls and messages).  Prior to the recent TRAI regulations prohibiting discriminatory tariffs, there was no specific law or regulation directly concerning the services provided by OTT service providers. How is net neutrality regulated? Until now, net neutrality has not directly been regulated in India by any law or policy framework.  Over the last year, there have been some developments with respect to the formulation of a net neutrality policy.  TRAI had invited comments on consultation papers on Differential Pricing for Data Services as well as Regulatory Framework for Over-The-Top Services (OTT).[i],[ii]  A Committee set up by the Department of Telecommunications (DoT) had also examined the issue of net neutrality.[iii] Internationally, countries like the USA, Japan, Brazil, Chile, Norway, etc. have some form of law, order or regulatory framework in place that affects net neutrality.  The US Federal Communications Commission (telecom regulator in the USA) released new internet rules in March 2015, which mainly disallow: (i) blocking, (ii) throttling or slowing down, and (iii) paid prioritisation of certain applications over others.[iv]  While the UK does not allow blocking or throttling of OTT services, it allows price discrimination. What do TRAI’s 2016 Regulations say? The latest TRAI regulations state that: (i) no service provider is allowed to enter into any agreement or contract that would result in discriminatory tariffs being charged to a consumer on the basis of content (data services), (ii) such tariffs will only be permitted in closed electronic communications networks, which are networks where data is neither received nor transmitted over the internet, (iii) a service provider may reduce tariff for accessing or providing emergency services, (iv) in case of contravention of these regulations, the service provider may have to pay Rs 50,000 per day of contravention, subject to a maximum of Rs 50 lakh, etc.[v] It may be noted that, in 2006 and 2008, TRAI had suggested that the internet sector remain unregulated and non-discriminatory (net neutral).[vi][vii] What are some of the key issues and perspectives of various stakeholders on net neutrality? TSPs and ISPs:  TSPs invest in network infrastructure and acquire spectrum, without getting a share in the revenue of the OTT service providers. Some have argued that the investment by TSPs in internet infrastructure or penetration levels would diminish if they are not permitted to practice differential pricing, due to a lack of incentive. Another contention of the TSPs is that certain websites or applications require higher bandwidth than others.  For example, websites that stream video content utilise much more bandwidth than smaller messaging applications, for which the TSPs need to build and upgrade network infrastructure.  The Committee set up by DoT had recommended that the TSPs may need to better manage online traffic so that there is better quality of service for consumers and no network congestion. Further, the Committee also said that in case of local and national calls, TSP (regular calling) and OTT communication services (calls made over the internet) may be treated similarly for regulatory purposes.  However, in case of international VoIP calling services and other OTT services, it did not recommend such regulatory oversight. Consumers and/or OTT service providers:  The Committee set up by the DoT said that the core principles of net neutrality (equal treatment and equality in speed and cost) should be adhered to.  It also said that OTT services (online content) enhance consumer welfare and increase productivity in many areas.  These services should be actively encouraged. In the absence of neutrality, the internet may be fragmented and not as easily accessible to those who are unable to pay for certain services. It has been said that discrimination of internet content by TSPs could be detrimental to innovation as the bigger market players would be able to pay their way out of being throttled.  This could potentially result in TSPs restricting consumers’ access to small-scale, but innovative or qualitative OTT services (restricting growth and innovation for start-ups too). Now that regulations regarding price discrimination are in force, we do not know whether TRAI or the government will enforce rules regarding other aspects of net neutrality.  Also, the extent to which these regulations would affect the business of TSPs and OTT service providers remains to be seen. [i] “Consultation Paper on Differential Pricing for Data Services”, the Telecom Regulatory Authority of India, December 9, 2015, http://www.trai.gov.in/WriteReaddata/ConsultationPaper/Document/CP-Differential-Pricing-09122015.pdf. [ii] “Consultation Paper on Regulatory Framework for Over-the-top (OTT) services”, TRAI, March 27, 2015, http://www.trai.gov.in/WriteReaddata/ConsultationPaper/Document/OTT-CP-27032015.pdf. [iii] “Net Neutrality, DoT Committee Report”, Ministry of Communications and Information Technology, May 2015, http://www.dot.gov.in/sites/default/files/u10/Net_Neutrality_Committee_report%20%281%29.pdf. [iv] “In the Matter of Protecting and Promoting the Open Internet: Report and Order on Remand, Declaratory Ruling, and Order”, Federal Communications Commission USA, February 26, 2015, http://transition.fcc.gov/Daily_Releases/Daily_Business/2015/db0403/FCC-15-24A1.pdf. [v] “Prohibition of Discriminatory Tariffs for Data Services Regulations, 2016”, TRAI, February 8, 2016. [vi] “Consultation Paper on Review of Internet Services”, TRAI, December 2006, http://www.trai.gov.in/WriteReaddata/ConsultationPaper/Document/consultation27dec06.pdf. [vii] “Recommendations on Issues related to Internet Telephony”, TRAI, August 18, 2008, http://www.trai.gov.in/WriteReadData/Recommendation/Documents/recom18aug08.pdf.