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:
| This month, PRS Legislative Research is 5 years old! The objective when we started out was to make the legislative process in India better informed, more transparent and participatory. From what started off as an idea, we believe we have made some progress towards our objective. - About 250 MPs across political parties have reached out to PRS for inputs on a range of issues that have come up in Parliament. In addition, there are a number of MPs who use PRS material for their preparation in Parliament, even though they have not contacted PRS for further inputs. - PRS has increasingly become a resource for the media as well. Over the past year, PRS has been cited on nearly 400 occasions by leading newspapers and websites as the source of information about legislation and Parliament. These are some of the milestones that we feel happy to have reached. But I want to really share are some of the learnings that we have had over these years. The first thing that we have learned is that many of us carry so many wrong perceptions about our MPs. Most of us don’t know that more than 80 percent of our MPs have college degrees. Most of us don’t know that the average attendance rate in Parliament is close to 80 percent in the past year. Most of us don’t know that Parliament has worked for more than 90 percent of the scheduled time in recent sessions, despite the undesirable disruptions in Parliament. There is a lot that is wrong with our politics, but we hope that some of these facts throw light about some lesser known aspects about our MPs. Laws are made for the really long term! That seems obvious, when we see examples such as our Indian Penal Code which was made in 1860, and the Land Acquisition Act that has haunted our country in recent years was passed in 1894. And these are just some examples. The fact is that if we do not debate our laws when they are being made, and citizens do not engage and provide inputs to this process, then we will be stuck with any issues that these laws might have for the next 100 years or more. So it is critical to get the laws as close to ‘right’ as possible when they are being passed. It is not obvious to most people that so many MPs put in significant effort to engage effectively in Parliament. Clearly, there is a selection bias, statistically speaking – I am talking of MPs who have reached out to us. Despite this selection bias, the point is that there are a number of MPs who take their work in Parliament seriously, even though they know that much of the work they do in Parliament has almost no bearing on their re-election prospects. (By the way, in most informal polls that I have done when I meet with groups of people, most do not know the role of an MP – even amongst some of the well educated groups.) Why do so many MPs still work hard to prepare for their work in Parliament, despite knowing that this work has no bearing on their re-election prospects? On this, we can only hypothesize. There are many MPs who understand their role as legislators and take it very seriously. There are MPs who feel that making a good point on an issue on the floor of Parliament is a way to establish their grasp of a certain issue to their colleagues in Parliament, but also to the larger world. For some others, it is a signalling device to their party colleagues about their interest and expertise in a certain subject area. And we have had MPs who have said, that they feel very good when other MPs, especially from other parties, compliment them for making a good point. All of these sound like good positive reasons for many MPs to want to be well prepared to speak in Parliament. We have begun to appreciate that the role of the MP in Parliament is very challenging. I can point to at least three reasons, which are independent of how educated or capable an MP might be: (a) The range of subjects in Parliament is so wide that no individual, however intelligent, can be fully conversant with all the subjects being discussed. (b) MPs have no research staff whatsoever, and are expected to do all of their preparatory work on their own, and (c) The constituency pressure on the MPs is often very high, making it difficult for them to pay adequate attention to their work in Parliament. We most certainly want more from our MPs and our Parliament. We want our MPs to meet for more days, find better ways to raise issues in Parliament than to disrupt proceedings, debate in more detail the laws that they pass. But what we have learned is that we cannot throw the baby out with the bath water. So, I am not suggesting that we can’t do better or that our MPs or our Parliament are perfect. The only way we will have a better Parliament is if we engage. And more people engage – from all walks of life. Policy making is not the exclusive preserve of either the expert or the policy maker. The policy process can be greatly strengthened if we participate in the process and ensure that our MPs know that we want effective laws to govern us and our children. Parliament can be made more effective by addressing some of the current bottlenecks. And some of these issues are not even difficult to fix. For example, can we have more people in the committee staff to support the work of the standing committees in Parliament so they can cover more ground in any given year? Can we have qualified research staff working for MPs so that they can go better prepared for Parliament? (Our Legislative Assistants to MPs – LAMPs programme has shown that it is hugely rewarding for young legislative assistants and the MPs if such a platform is created.) Can we have recorded voting on all legislative votes, instead of voice votes – the electronic button system is already in place to do this! These are just some examples… and we at PRS have a laundry list of ideas for strengthening Parliament – with varying degrees of difficulty. We have raised some of these issues in our Annual Conference of Effective Legislatures, and will continue to do so in the years ahead. A very BIG thanks to each of you for making PRS possible over these past five years… We hope that you will continue to bless and support us in the years ahead to help shape a more robust policy making process in India. | PRS PRODUCTS The Legislative Briefs are our flagship product. Each Brief analyses one Bill pending in Parliament. These are no longer than 6 pages and are sent to all MPs. We then get calls from MPs asking for more information/ clarification. Since earlier this year PRS has begun a Wednesday morning Policy Dialogue series exclusively for MPs. These are widely attended by MPs across parties. PRS is the knowledge partner to brief MPs in the Thursday morning Bill briefing sessions organised by the Constitution Club. PRS has reached out to about 1000 journalists across the country, through journalist workshops and direct engagement. PRS has started the Legislative Assistants to MPs (LAMPs) programme as a pilot initiative. Under the programme, participating MPs get a trained legislative assistant for a period of three Parliament sessions. PRS produces Primers to demystify Parliamentary process for citizens. These are widely used in our interactions with civil society groups. The Vital Stats series is a crisp two page document that often highlights interesting aspects of Parliament. They are very popular with journalists. PRS has nearly 1000 fans on Facebook and 2000 followers on Twitter, including some MPs. PRS has a Session Alert at the beginning of each session of Parliament. On the last day of each session, PRS releases two reports on the just concluded session: Parliament Session Wrap and Plan vs. Performance. PRS hosts an Annual Conference of Effective Legislatures each year to highlight certain aspects of the functioning of Parliament. PRS has compiled a free online database of all state laws across the country. This effort www.lawsofindia.org is the first effort of its kind in India. The PRS website www.prsindia.org has become an important resource for anyone tracking the Indian Parliament both within the country and abroad. |
