India: Genericisation Evokes Fierce Debate At Third Edition Of Vantage Point

A fiery debate on 'Genericisation: Panacea or Pandora's Box?' ensued at the third edition of Vantage Point, Express Pharma's platform to discuss and deliberate on Indian pharma sector's most pressing and controversial topics. Partnered by Wellness Forever, the event was held at Sofitel in Mumbai. An eminent panel deliberated on the implications and possibilities of the Centre's push towards genericisation of pharma brands, in a very interesting and insightful session, moderated by Dr Milind Antani, Head, Pharma and Life Sciences, Nishith Desai Associates.

The panel comprised Dr Amar Jesani, Editor, IJME; Dr Jayesh Lele, National Secretary – IMA Board of India; Milind Mangle, Internationally Certified Coach and Consultant, Angle Consultancy & Services; Vaijanath Eknath Jagushte, Treasurer, Chairman of Legal Affairs Committee —AIOCD & MSCDA and Treasurer of MSCDA; Priti Mohile, Managing Director, MediaMedic Communications;

Dr KS Sharma, PG Committee Member, Medical Council of India MCI and Director Academic Tata Hospital; Daara Patel, Secretary General, IDMA and Dr Suleiman Merchant, Dean, Lokmanya Tilak Municipal General Hospital and Medical College.

Dr Antani drew out the panelists to share their views candidly and discuss the ramifications of a mandate to prescribe only generic names of drugs. He steered the debate to touch upon lesser discussed points and look at the issue in a more detailed manner. He also threw light on many legal aspects of the issue and explained the various grey areas to give more clarity on the same. Dr Antani, in the course of his moderation, quipped that the Indian lifesciences industry is facing a challenge between choosing what is ethical and what is legal.

Industry representatives were openly critical of genericisation. They viewed the move with disfavour and highlighted various pitfalls which would arise if genericisation became the law. Do all generic medicines give the same results as their branded counterparts? Are enough generic medicines available in market? While focusing on price, how do we not lose sight of quality?These were some of the questions posed by experts and veterans during the debate.

At the same time, there were panelists like Dr Jesani who was totally in favour of prescribing generics. He outlined the various advantages in terms of access and affordability of medicines. He said that if there was political will and collaboration between stakeholders, then genericisation could indeed be a panacea and create significant positive impact for patients. At the same time he admitted that there is a need to have better monitoring mechanisms in place to ensure effective implementation of the government's push towards generics.

Opining that genericisation is a populist move, Dr Lele questioned the preparedness of the government to implement it effectively. He said that quality can be a concern in such a scenario as the industry and medical fraternity is illequipped to deal with genericisation. He lauded the intent of the government but expressed reservations about effective implementation of the move.

Mangle pointed out that this is a very multifaceted issue and would have widereaching implications. He explained the rationale of the government behind pushing generics and stated that though the intention was to introduce a panacea to many problems faced by healthcare industry today, inadvertently opened a Pandora's Box. He said that our public and other stakeholders are still uninformed about various issues and hence not ready for a step like genericisation. He pointed out the various complexities arising from the move and said that lack of accountability is one of the major concerns in this situation.

Mohile was in favour of genericisation but she too had doubts about the step being successful in achieving its objective. As a communication specialist, she threw light on how marketing and PR would change in times of genericisation and its effect on patients. She also said that information about quality will become paramount in future.

Jagusthe expressed concerns about ensuring quality and said that it is a premature move. He pointed out that there is no standardisation in India as far as quality is concerned. He opined that unless quality is assured through proper regulations and infrastructure, enforcing prescription of only generics is not a good decision. He lauded Jan Aushadhi as a good initiative to make medicines available but recommended strengthening it with better economic policies to make it sustainable and extend its reach.

Dr Sharma gave instances of how genericisation can fail in implementation and raised concerns about quality, accountability and efficacy. He said that the government's intention to nullify the nexus between the medical fraternity and pharma companies might not really succeed as the wrongdoers might find ways to circumvent the move and continue with the malpractices. He also pointed out to various grey areas which may prevent the move from being a beneficial one, for instance, crosspathy practitioners do not have to adhere to these guidelines.

Patel was emphatic that 'generics only' is a decision which will not serve any objective. He stated that other measures to reduce prices might be more effectual and claimed that the industry would support the government if they come up with better strategies to serve the masses. He recommended slashing taxes of essential medicines as a measure to reduce prices of drugs.

Quality was a concern raised by Dr Merchant as well. He said that until the right standards, infrastructure and regulations are put into place to determine the efficiency and efficacy of drugs in India, genericisation will not be successful. He was also of the opinion that it is an idea whose time has not arrived yet.

Thus, the panel was divided in its opinion about government's decision to promote generic medicines. The panel discussion was followed by a Q&A session. Viveka Roychoudhury, Editor, Express Pharma and Healthcare posed the first question. She asked whether seminars held for associations help in maintaining the quality of medicines and in educating patients to take a good decision? To which Patel responded that they have already got an approval to add a topic on generic medicines to the existing seminars.

SR Vaidya, Chairman, SME committee, IDMA, suggested that there must be seminars held on quality of excipients as they constitute 95 per cent of the drug. He insisted on making pharmacovigilance activities mandatory which can increase the quality standards of generics.

Deepak Paliwal, External Advisor, GSK, London, connected with the audience and panelists through Skype. He was in favour of the government's move and threw light on a pilot project in the state of Andhra Pradesh where pharmacists are prescribing generics for past three years. He further clarified the government's motive behind mandating writing the generic name in capital letter is to ensure more readability among patients and pharmacists. Akash Rajpal, MD and CEO, Ekohealth Management Consutants, raised a set of legal questions related to the liabilities of doctors while prescribing medicines. He asked, "Is a doctor liable when s/he prescribes a branded medicine of their choice and something goes wrong? Also, if the doctor is not liable in this case, then how can s/he be responsible when s/he prescribes a generic medicine? Are there any drugs available at pharmacies that are not FDA approved?"

Mangle replied saying that as of now, doctors can be held accountable for the various brands they prescribe. While prescribing generics, the patient might not know who to hold responsible as the liability might keep shifting among various stakeholders.

Further on, the panelists highlighted the importance of bioequivalence studies and the need for standardisation to build trust. On the contrary, Dr Jesani raised a point that in case of substandard drugs, the manufacturers are to be held liable and the regulators like CDSCO should be more attentive towards any spurious drugs available in the market. He also suggested that more investments need to be made in order to bring each company under their surveillance.

Sripad Desai, Americares, inquired that even if doctors prescribe a generic medicine, will the pharmacists be able to dispense branded ones? The panelists expressed that substitution is against the law and there is a need to take a few learnings from the US where unique codes are allotted to each formulation.

Payal Laad, Professor, Community Medicine, Sion Hospital, referred to Bangladesh's drug model and asked what can be the takeaways for India. Patel, informed that the Indian state of Rajasthan has a similar policy but, there are few hurdles faced while extrapolating these schemes across India.

Dr Gopal Dabade, President, Drug Action Forum of Karnataka asked whether generic medicines can be available at affordable prices, to which the panelists responded that there is an urgent need to tackle the nexus between manufacturers, doctors, and chemists for patients' benefit.

The event came to close with the panelists unanimously agreeing that patients' wellbeing should be safeguarded at all costs. Therefore, before the government mandates generication of medicines, they need to put in place the required processes to ensure that quality generic medicines are made accessible for all

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Sign Up
Gain free access to lawyers expertise from more than 250 countries.
Email Address
Company Name
Confirm Password
Mondaq Newsalert
Select Topics
Select Regions
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions