Citizens' Issues
Generic Medicine Prescription: Treat the Cause, Not the Symptom
Prime Minister Narendra Modi’s recent call for generic medicine prescription mandatorily by the physicians with a view to reducing the cost of healthcare, and the likely law surrounding it, is the culmination of three decades of effort to provide affordable healthcare to the poor. Doctors in government hospitals are mandated to prescribe only generic drugs. Moving from branded generics to generics, with most pharmacies and medical stores manned by unqualified or semi-qualified persons, would be well-nigh impossible, because 50% of drugs are combination drugs.
 
A number of studies conducted elsewhere in the world point out the factors influencing the generics’ prescribing behavior. While the patient’s financial status, welfare, compliance, and fear of punishment are positive factors, quality concerns, lack of regulation by Food and Drug Administration (FDA), poor recall of generic names, patient’s preference and personal experience are negative factors influencing the generics prescribing behavior.
 
A qualified physician checks the causes of an illness and treats the patient after a few diagnostic tests, while quacks treat on the basis of symptoms. Insights into the ecosystem of pharma health care in India will help understanding the burden of our arguments:
 
1. Too Many Brands, Loan licensing and Pharma-Physician Nexus 
There are about 92,000 branded generic formulations today. Loan licensing allows manufacturing of fast moving drugs (largely prescribed molecules or fixed dose combinations) yielding higher margins for the investors. A pharmaceutical representative, manager or a physician or a group of physicians with sizable clinical practice can start a pharma company easily. Such pseudo manufacturers colluding with willing physicians, under mutually agreeable terms of contract, share the gains, leaving the pain to the poor patient. Competitors with deeper pockets can easily persuade them to prescribe their products by increasing the transactional sum. This leads to a continuous escalation of marketing costs at the expense of patients.
 
2. Regulatory Standards 
India’s current drug regulatory mechanism has inherent inefficiencies and inadequate infrastructure. There is a vast difference in the quality of generics in India and elsewhere in the world. In the US and other well regulated markets, stringent quality control measures ensure effectiveness of generics administered on patients, through bioequivalence tests at the USFDA approved laboratory. Mere comparisons with innovator drug of chemical equivalence does not make it therapeutically equivalent. All this costs a lot and puts an entry barrier on fly-by-night operators. The technical infrastructure in India is grossly inadequate for quality testing and certainly not comparable with the West. 
 
Most of the generic formulations are not tested by comparing them with the leader of the branded generic formulation or the brand-name drug for bio-equivalence, and yet they are approved.  Many of the reported close to 10,000 drug companies do not have a manufacturing facility that conforms to and approved by the World Health Organization’s Good Manufacturing Practices (WHO GMP).
 
The loan licensing system enables start-ups having a million rupees to enter the market with their own generic, creating competing spaces at national, regional and local levels. How will the Drug Controller General of India (DCGI) ensure that the patients get the same quality of generic drug as the branded drug? A branded drug manufacturer has his reputation at stake while the generic manufacturer has little to lose.
 
3. Continuous Cost Escalation of Medical Education 
The pharma-physician nexus is deepening by the day and along with it are the irrational prescriptions of expensive branded drugs. The ever increasing cost of medical education, both at the graduation and specialty level, are driving the new entrants into medical practice to recover their education expenditure through unholy contracts with pharma companies. Neither the government nor the Medical Council of India is able to do anything to curtail the capitation fee system in private medical colleges, the root cause for corruption among dotors.
 
4. Shortage of Qualified and Trained Pharmacists in Retail Pharmacies
It is pathetic that most of the 7.5 lakh retail pharma outlets do not have qualified pharmacists at the shop floor. Even the compromising solution suggested by the government, to train the sales persons of these shops, is yet to see the light of day. What is more, the curriculum at the graduate level in our pharmacy courses does not include many of the new drugs that are recently developed. Empowering the not-so-qualified pharmacist to dispense generic drugs can do more harm than good to the patient.
 
5. Breaking the Pharma-Physician Nexus or Creating a New Pharma-Pharmacist Nexus? 
The other root cause of the problem lies in the hierarchy of pharmaceutical products – innovator-branded medicines, value added drugs – those that carry the same molecules with a perceptible premium and branded generics and generics, in that pecking order. Go to any corporate hospital: medicines prescribed there with the highest premium are available only in the attached pharmacy.
 
The contemplated legislation on compulsive generic drug prescription would have the distinct possibility of therapeutic prescription carrying the best price that would make the manufacturer-retailer nexus coexist with the physician-pharmacist nexus, making it a win-win situation for everyone – barring the patients. The solution lies not so much in law as in cleaning up the entire supply chain that includes the drug controllers.
 
6. Absence of Good Governance 
That there is clearly a lack of good governance is evident from the fact that the government has been unable to ensure compliance from all the stakeholders despite the presence of well-defined rules governing the manufacturing and selling pharmaceutical products in India such as the Drugs & Cosmetics Act, Voluntary UCPMP (Universal Code of Pharmaceutical Marketing Practices), MCI (Medical Council of India) etc. Yet another law makes no big difference.
 
Evolution or De-evolution?
The modern pharmaceutical industry as we know it today has evolved over many years and contributed significantly to the discovery and development of important drugs. The same industry has to develop future cures too. Therefore, it has to continuously evolve around investments in research and innovation. Let the industry be encouraged to continue in the evolution process. 
 
The Way Forward: A Prescription
 
  • To change this negative perception of generic drugs, all we have to do is approve every generic formulation based on a bio-equivalence test, comparing it with the reference drug (either the brand name drug or leader brand of the branded-generic drug). If this is made mandatory the quality of the generic drugs would improve significantly.
  • Ensure that a qualified and trained pharmacist, who has adequate knowledge about drugs and diseases and can improve health awareness among patients, mans all retail pharmacies.
  • In order to bring a sustainable and lasting change in behavior, introduce recognition and reward systems among physicians who prescribe more generic drugs and make the names public to accelerate the rate of generic drug prescription.
  • Strengthen the Drug Administration Department with adequate manpower to ensure compliance and establish good manufacturing practices (GMP) among all manufacturing units.
  • It must be mandatory for a loan licensee currently leveraging on outside manufacturers to manufacture in its own manufacturing unit within a specified time, failing which the unit’s license will be cancelled after the notice time. This will rationalise the number of drug manufacturing units, improve their productivity and the overall quality of generic drugs. It would also help in stopping the pharma - physician nexus.
 
Currently, there are an estimated 92,000 pharmaceutical products in India, of which about 60 per cent are different versions of branded-generic or generic versions of single ingredient drugs. It is necessary to impose a cap on the number of generic formulations for each single-ingredient drug. This is by no means exhaustive. It is only to start the process of thinking holistically with a singular purpose of treating the cause(s) and not merely the symptom(s).
 
(Ch SVR Subbarao is former Director for Marketing at Sun Pharmaceuticals Ltd and Dr B Yerram Raju is an economist and risk management specialist.)

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COMMENTS

Ulhas Karkhanis

4 weeks ago

This is a comprehensive view presented on one of most widely discussed issues related to healthcare. In the absence of a strong infrastructure, new policy to promote generic prescription will fail in achieving its ultimate objective of reaching out to masses at affordable prices.

Srinivasan Athmanathan

4 weeks ago

This article by Sri Subbarao is an eye opener to all those who are concerned about medical products pricing as well as theraupetic effect. All Government agencies at State and Central level must read this article and understand the issue thoroughly. As already stated, there is a class of pharma companies, colloquially known as PCDs (Propaganda Cum Distribution Companies) having great days in Indian Pharma Market. The proliferation of such PCD companies are hindering the growth of organized pharma industry per se. The nexus between PCD companies and practising physicians is a well known secret. What matters the most is that the Governmental Agencies must make monitoring and controlling system in place with appropriate infrastructure, before introducing any such policy decisions.

Ramesh Poapt

1 month ago

excellent, Sirs..!

Harbhajan lashes out against 'racist' Jet Airways pilot
New Delhi, Veteran cricketer Harbhajan Singh on Wednesday lashed out against a Jet Airways pilot for racial discrimination against a fellow Indian passenger on the flight.
 
The Punjab tweaker, who is currently playing for the Indian Premier League (IPL) side Mumbai Indians, took to Twitter to reveal that the pilot, named Bernd Hoesslin, "physically assaulted a lady and abused a physically challenged man" besides calling them "bloody Indians".
 
In a series of tweets, the off-spinner, popularly known as the 'Turbunator' hit out at the airline's pilot for disrespecting an Indian despite himself making his earning on the Indian soil.
 
"So called this Bernd Hoesslin a pilot with @jetairways called my fellow indian (u bloody indian get out of my flight) while he is earning here," Harbhajan wrote in his first tweet.
 
"Not only was he racist but physically assaulted a lady and abused a physically challenged man...absolutely disgraceful & shame on @jetairways."
 
Demanding strict action against the pilot, the 36-year-old cricketer wrote: "Strict action must be taken & such things should not be allowed or tolerated in r country... #proudtobeindian let's get together and sort this."
 
Harbhajan took some time out to travel with his friends and family. He went for a short trip to Alibag on Tuesday and uploaded a video of the trip on social networking site Instagram.
 
Disclaimer: Information, facts or opinions expressed in this news article are presented as sourced from IANS and do not reflect views of Moneylife and hence Moneylife is not responsible or liable for the same. As a source and news provider, IANS is responsible for accuracy, completeness, suitability and validity of any information in this article.

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COMMENTS

Simple Indian

1 month ago

Jet Airways should have no problems sacking this expat pilot as he's neither a Dalit nor a Muslim, and hence not above law. No politician is likely to back him for aforesaid reasons either.

Vinay Isloorkar

1 month ago

That pilot must be made to see stars. The least we expect is Jet should sack him.

SC calls for statutory regime to regulate NGOs, state funding
New Delhi, The Supreme Court on Wednesday asked the Centre to consider putting in place a statutory regime to regulate the registration, funding, compliance and audit of the NGOs getting state support.
 
A bench of Chief Justice Jagdish Singh Khehar, Justice D.Y. Chandrachud and Justice Sanjay Kishan Kaul asked the government to consider giving a statutory status to the entire process. 
 
This legal regime might also envisage the civil and criminal action against the defaulting NGOs as deemed fit by the legislature. 
 
Observing that the existing guidelines were not systematic, the court in its order also asked the Centre to tell whether it would opt for a statutory regime or continue with the present guidelines.
 
The apex court gave the Centre eight weeks' time to tell the court its stand.
 
However, it also made it clear that its order would not come in the way of any ongoing proceedings, including civil and criminal action against the NGOs.
 
The court order came on a PIL seeking to make NGOs accountable for the expenditure of the funds received from the government. 
 
Disclaimer: Information, facts or opinions expressed in this news article are presented as sourced from IANS and do not reflect views of Moneylife and hence Moneylife is not responsible or liable for the same. As a source and news provider, IANS is responsible for accuracy, completeness, suitability and validity of any information in this article.

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COMMENTS

Simple Indian

1 month ago

Yes, it's high time the Govt enacts a law to define who should be an NGO (usually in the social sector) and lay down strict guidelines for who can be a professional social worker. In most developed countries, one has to have be a graduate/PG in social work/sciences and clear exams to get a license to practice as a 'social worker'. But, in India, any jhola-clad person can claim to be a 'social worker'. Moreover, many NGOs in India have been getting donations/funds from abroad, with no accountability on how these funds are utilized. Many genuine social activists have time and again exposed nexus between agenda-driven NGOs getting funds from abroad mainly to oppose development work in India. Many also get for proselytizing (Christianity / Islam) which should be stopped. Besides, many well-known NGOs in India, like CRY, HelpAge, employ people in their top positions who have corporate executive style designations, salaries & perks, and lifestyle. All this maintained from funds they seek in the name of their clients/target group for 'social service'. When even small housing societies are required to be registered and their accounts audited periodically, why should NGOs be exempt from such scrutiny, particularly when they get funds from common public, ostensibly for supporting underprivileged sections of society ?

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