The government plans to re-brand the Jan Aushadhi initiative by opening 1000 centres across India by this June. Will this breathe new life into the initiative? By Usha Sharma
The Jan Aushadhi scheme, launched in April 2008 by the then Union Minister of Chemicals & Fertilisers and Steel Ram Vilas Paswan, started with the objective of improving access to affordable medicines. The idea was to set up special outlets known as Jan Aushadhi stores in each district where generic medicines would be available to the general public.
But seven years down the line, the initiative was nowhere near achieving this objective with only 98 centres of the 178 centres functional.
It is clear that implementation was not up to mark. As Dr Rajaram Samant, Chief Executive Officer and Chief Mentor, Akumentis Healthcare points out, “As a concept, it is a great initiative to ensure the accessibility of affordable medicines for the people of the country. These noble intentions have not lived up to the expectations of public in general for two reasons; lack of quality standards prescribed to ensure that medicines available are of good quality and shortage of critical medicines all the time. This has lead to a huge trust deficit in the minds of practitioners and the public. There is an underlying nexus between chosen few manufacturing units and retail stores as well. Hence, there is a need to not only re-brand but also to address the above mentioned critical issues as well.”
A fresh lease of life
Heeding such industry feedback and going solely by the numbers, the new government at the centre looks keen to breathe new life into Jan Aushadhi. And intends to start with a bang: Hansraj Gangaram Ahir, Minister of State for Chemicals and Fertilisers recently announced that the Union Government would open 1000 new Jan Aushadhi centres on a single day in June as well as re-brand the initiative.
Industry reaction to these announcements have been measured but optimistic. Welcoming the move, Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI) says, “We welcome the Indian Government’s effort to breathe new life into the stagnant Jan Aushadhi initiative.”
The government’s move to rename the Jan Aushadhi initiative, is to create an awareness among the population and also help in creating a better visibility of the programme. Commenting on re-branding the initiative, Anay Shukla, Member, Pharma and Healthcare Practice, Nishith Desai Associates says, “Renaming the scheme is a prerogative step by the government. The objective of the scheme is positive for the benefit of patients at large. Re-branding the scheme is likely to give thrust and better acceptance by patients.”
Challenges ahead
It is ironic that even though Indian pharma companies rank among the top performers in the global generics market, offering quality medicines at affordable prices to patients across the world, an initiative to do the same within the home market floundered for seven years.
As Dr Ajit Dangi, President and CEO, Danssen Consulting informs, “The old scheme of Jan Aushadhi which was launched in 2008 is already struggling to survive. The new scheme is a fresh lease to infuse some life into the old. So far less than 200 shops are functional under the old scheme and study shows that mean availability of medicines was only about 33 per cent, largely because of dependence on public sector units for supply. The drugs are expected to be supplied by the Bureau of Pharma PSUs of India and will be co-ordinated by Indian Drugs and Pharmaceuticals Ltd (IDPL), Gurgaon.”
Therefore the opening of 1000 new centres is a great idea but the key challenge lies in execution and ensuring that the end consumer does not end up with fake or spurious medicines.
Expressing his concerns, Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates suggests, “India needs to expand and deepen its reach for public distribution and available access for medicines especially to the rural masses. However, medicines without qualified pharmacists (for informed dispensing) and medical professionals (doctors, para-medicals) does not serve any purpose. Therefore, the proposal made by the ministry which seems to entrust one Jan Aushadhi outlet to one skilled pharma or medical professional to establish, manage and operate appears workable. Though it sounds ambitious to commence from June this year, a beginning can be made with qualified applicants/ aspirants to join the project. This is a welcome initiative.”
Smetacek too feels that opening up 1000 new Jan Aushadhi centres across India with a new name in a single day sounds interesting but presents challenges as well. She opines, “It is a big challenge to ensure a consistent supply of quality medicines, in well distributed outlets across the country. A professional approach is required and this would entail a motivated leader heading the initiative; appropriate focus on supply chain, logistics and warehousing; awareness building efforts to change existing perceptions, among other things. The industry will cooperate to support the government’s efforts in this area.”
While agreeing that the implementation of the initiative in the past few years could have been better, Dr Milind Antani, Partner Pharma and Healthcare Practice, Nishith Desai Associates says, “There is no doubt that the government has the capability to run the scheme and also to scale it up in the years to come. Jan Aushadhi scheme (stores) does not require significant infrastructure and resources to function. Since the Central and state governments have the infrastructure and resources to administer various other health schemes and hospitals, it can successfully implement Jan Aushadhi scheme and manage stores as well. However, it would definitely require commitment and dedication to make it successful.”
Dangi informs that he has already put the proposal to the government to invite private players for the initiative. “The government is now mulling over the proposal to invite private sector for the scheme. To make the scheme more viable, it is also proposing to make it mandatory for the medical profession to prescribe only generic medicines. While this move is supported by Indian Medical Council, it is strongly opposed by Indian Medical Association and rightly so. Unless the issue of quality, safety and efficacy is resolved and a strong regulatory oversight is in place, the medical profession as well as the patient population are unlikely to trust the generics,” adds Dangi.
But given the inertia of the past seven years, sceptics abound. Nair feels that the as the ministry may not be able to manage this by themselves, they will need to set up an independent entity well-manned with trained or experienced professionals committed to the cause.
Giving some options, BG Barve, Joint Managing Director, Blue Cross Laboratories says, “The model automatically has to be public-private-partnerships (PPPs), where the industry manufactures and provides generic drugs at heavily discounted rates and the government distributes these drugs through the shops and other centres. The government will again have to factor in retailers’ margins. It could be possible if they manage to rope in existing chemists/ retailers interested to join the scheme.”
Antani too advocates the PPP model to improve accessibility of the programme. As he reasons, “The government has announced that it will seek participation of private players for supply and distribution of drugs in the scheme. In future, a partnership model (PPP) may be rolled out as well. We feel that proper implementation of PPP model would give necessary impetus to the scheme.”
Realising the cost factor, which will play a key role in the initiative, providing affordable quality medicines will be not so easy and PPP model will not work that effectively.
But the PPP model too will present certain challenges. As Samant points out, “It will be extremely difficult to manage the PPP model and provide quality medicines as it will require tremendous commitment and resources from government. The government needs to set up standards for all the medicines which are global in nature, and ensure a process by which these standards are monitored. The same will increase the cost of medicines many fold.”
Besides the PPP model, the government needs to look at other options as well. Barve suggests that they could also consider expanding the scheme through post offices to promote generic drugs.
Drawbacks
It is likely that even after its revamp, the Jan Aushadhi initiative will face various hurdles during its implementation process. Nair emphasises, “Drawbacks are plenty. Mismanagement, diversion, opportunistic substitution with spurious medicines at outlets, uninformed consumption are disadvantages. Above all, the conflict with Drugs & Cosmetics Act and other provisions, need to be resolved.”
Pharma companies are already anticipating a new set of hurdles. Touching on one of the foremost of these, Barve says, “Quality in healthcare in India is best assured to public through brand names. Any attempt to abolish brand names and to push generic — generic products may not be the right solution and would be counter-productive and not in favour of the patient. To impose unbranded generics on patients will allow retail chemists to push products with better margins instead of the medical fraternity advising patients to purchase trusted and assured generic drugs from respected manufacturers with long standing reputation for quality products.”
There are also those willing to give a fair chance to the government’s efforts, keeping in mind the intended benefits to the end consumer. Shukla explains, “The single and most important benefit of Jan Aushadhi scheme is its ability to ensure cheap and easy access of medicines to needy common people. There are no draw backs in particular, however, one issue that comes up off and on is quality and service. Availability of certain drugs which are required could be one of the factors that may reduce the pace of scheme. Some of the areas in which it could improve are the number of drugs which are presently covered, geographic reach of stores, ease of participation of private sector players, cost burden (though relatively miniscule) on the purchaser and services being offered and acceptance.”
Will quality be an issue?
A more worrying stumbling block could be issues related to quality of the medicines sold under this scheme. Nair prefers to repose confidence in the government on this front, saying, “Department of Pharmaceuticals, Government of India will be able to source quality medicines and assure quality as well as build confidence on the quality of Jan Aushadhi medicines. These will, anyway, be subject to inspection, drawing of samples for quality testing, storage inspections etc. by drug inspectors under Drugs & Cosmetics Act. This will guarantee quality and instil confidence.”
Global pharma regulators have pulled up pharma manufacturers in India for various GMP violations giving rise to drug recalls but Barve points out that to date, no product has been forced to be recalled due to any quality issues per se; it has been more of documentary negligency, issues of data integrity etc.
“India manufactures and exports over Rs two lakh crore worth of safe and efficacious generics. Many global NGOs such as MSF, UNICEF, IDA etc. have publicly recognised India’s quality generics and affordable prices and rated India as the best and largest supplier. India has earned international recognition for our commitment to safe, efficacious and quality affordable drug therapies both within our own domestic market and through exporting the same medicines to people in other countries.”
But the perception created by recent drug recalls and similar regulatory actions will have an impact. As Dangi says, “Unless the issue of quality, safety and efficacy is resolved and a strong regulatory oversight is in place, the medical profession as well as the patient population are unlikely to trust the generics.”
Along these lines, Antani avers that as all medicines supplied to Jan Aushadhi stores are supposed to be tested at a government testing laboratory, the government may have to increase the number of recognised laboratories.
Outlook
Inspite of the challenges, the Jan Aushadhi initiative remains an idea that needs to be implemented on a war footing. As Barve says, “The availability of medicines and health facilities in the hilly, tribal and inaccessible areas are either absent or inadequate. Therefore, such areas need to be given special treatment in a mission-mode approach, through which the health services and medicines are provided at affordable rates/ prices. The Jan Aushadhi scheme needs to be expanded to cover these areas. There is also a need to ensure access of common man (poorer section) to medicines through public hospitals etc. Industry supports such objectives of easy accessibility of medicines to common man. To ensure that the common man is truly benefited, all formulations supplied to hospitals, serum vaccines and biologicals under public health programmes should be kept out of the purview of price control.”
Giving another perspective, Dangi adds, “If improving access and providing poor patients affordable drugs are the key objectives, then priority should be given to expand the health insurance coverage, strengthening the regulatory system, focus on prevention rather than cure and exempt essential medicines from duties and taxes and unreasonable trade margins.”
Finally, while the revamp of the Jan Aushadhi was necessary, will it enough to assure its success the second time around? Signing off, Samant cautions, “Unless radical changes are done, the same story will continue at a much larger scale and will drain resources from the government.”
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