Generics vs Branded Generics

Doctors and pharmacists have raised several concerns over implementation of GOI to prescribe only generic medicines to the patients. So has the Pharma Industry and professionals attached to it. Big wigs of India's leading drug companies met recently in Ahmedabad to take stock of a recent diktat by the health ministry on prescription of medicines by their generic name.

Not generalising all doctors but too much hoopla going around !

IMA says that MCI order does not prohibit a doctor from writing the name of the company or the brand.The question is how many doctors have been really prescribing rationally anyway? What's the reason of so much antibiotic resistance in India ? Aren't doctors over treating patients at all ?

Few Doctors I know and enquired had following queries :

1. Are the doctors allowed to practice evidence based medicine in india?
2. Do the Patients have patience ?
3. Can the pharmacists stop doing over the counters practice?
4. Are the generics in india low priced or equally priced?
5. What is the reason for overnight decision on generic implementation . ?
6. Can generic drugs usage be made mandatory like this?
7. Does the things become as usual without any implementation as happened earlier as this topic was not raised for the first time in indian political/policy scenario ?

The issue of generic drug prescription returned to the spotlight after Prime Minister  said last week that the government would bring in a law to force doctors to prescribe medicines by their generic names. Bringing in generic name prescriptions will be a path breaking step for the government. Mr Modi's proposal is seen as an attempt to bring expensive drugs to poor Indians, and also as a not-so-subtle swipe to regulate the DOCTOR-DRUG COMPANY NEXUS considered to be one of the reasons patients have to pay more for their medical expenses. 

This was followed by the ministry’s directive. The thought behind this initiative is to reduce the medicine costs for families that have a member suffering from a disease or disorder. This is a very fair expectation as high healthcare costs can wreck a family’s financial health. But given the ground realities of our inefficient and inadequately manned regulatory infrastructure and poorly invested healthcare delivery system, it could end up being an exercise in futility and chaos.

India’s pharma market worth over Rs 1 lakh crore is dominated by branded generics. This notice has taken companies by surprise who fear such a move would dent the industry which is already reeling under external issues of quality and price control and GST preparedness.

It is not understandable why such an arbitrary action has been taken without discussing with the stakeholders;-- Over 10 lakh jobs of medical representatives would be at stake with this move.

On April 22, the Medical Council of India has asked the medical community to follow its 2016 notification in which the MCI had amended the clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 mandating the doctors to prescribe medicines by generic names in place of brand names preferably in capital letters, and ensure that there is a rational prescription and use of drugs. The circular was issued to the Deans, Principals of Medical Colleges, Directors of all the hospitals, Presidents of all State Medical Councils.

The MCI notice doesn’t say that doctors should not write brand names, it says that physicians ‘should’ mention generic names.

People are interpreting this incorrectly.

Doctors have their own reservations -- say patient will have to take fistful of generic medicines if the compulsion continues. The generic medicines for many diseases related to heart and brain are not available in the market. The doctors claim that most of the times, the name of the drugs are so complicated that many pharmacists may go wrong in identifying the prescribed drug.

Several issues are likely to come up during actual implementation of the decision. Drs cannot give assurance that the patient will get the drugs prescribed by them. If the drug turns out to be ineffective then the doctor should not be held responsible.  The real issue lies in implementation as most of the medicines available in the market are combination of drugs and in such cases the cost to the patient for buying three to four prescribed components of the single medicine may be higher than a branded medicine.

The transition to generics is a long term aim where the first step needs to be quality.The Centre's steps to make doctors prescribe drugs by their generic names and not by their brand names may not have material impact without steps for improving the quality standards for drugs.

The Central Drugs Standard Control Organisation, the national drugs regulator in a report, listed as substandard popular over-the-counter medicines such as D Cold Total, Combiflam, Cetrizine, Paracetamol, Pantoprazole, Ofloxaci and Lomotin. Combiflam, a painkiller manufactured by the Indian unit of French drugmaker Sanofi, had failed in similar tests last year as well. Several batches of Combiflam were withdrawn from the market after the regulator found the lots were substandard.

The list features 60 common drugs which are all labelled "Not of Standard Quality"; the reason given in most cases is "Description and Particulate Matter" or "Disintegration" - which refers to time taken for the medicines to disintegrate or break down in the human body - an important parameter for routine assessment of pharmaceutical drugs.This year’s list includes painkillers, medicines for anti-allergy, fever, cold, loose motion, constipation, as well as calcium and iron supplements, among others. Some of these medicines are manufactured by big companies such as Cipla, Cadila, Sanofi.

If such are the state of affairs with Branded generics one can imagine what is the scenario with quality of GENERIC medicenes available from mushrooming companies .

It also needs to improve and standardise the drug approval process in India.

• A shift to a generic-generic model (similar to US) from the branded generic model currently in India, requires confidence among doctors, pharmacists and patients on the quality of drugs available in market.
• The key focus of the government then needs to be towards strengthening and empowering the regulator.
• Prescriptions by generic names will shift the brand selection power to pharmacist.
• This move towards a generic-generic market is negative for the Indian pharmaceutical companies.
• The focus of companies, in the current environment, will then shift to pharmacists for marketing their drugs.
• At the pharmacy level, generic-generic drugs have much higher margins than branded drugs

A study in Indian Journal of Pharmacology found that while generic versions were less expensive than the branded ones, the retail margin on generic variants was way higher - sometimes more than 1,000% of the manufacturer's price.This implies that retailers have a strong financial incentive to push GENERICS, even if doctors prescribe branded.

Ironically, India is one of the world's largest exporters of generic drugs. It exports to over 200 countries, including the highly regulated markets of US, Europe, Japan and Australia. But the experts say quality control is much better abroad. There are only 1800 drug inspectors in the country. This number is grossly inadequate.Less than 0.01 percent of the drugs produced in the country are tested for quality. "For doctors to prescribe generic drugs, it is crucial that the laws regarding drug testing and quality assurance are strengthened..

One of my senior professional collegue from pharma industry opined that this Pharma Industry ended up as a cottage industry where any body and every body can market pharma products under their brands. Marketing had stopped down to freebies including cash thus a torrent of brands for any single pharmaceutical product. He being active in industry and at the helms of a very senior responsible position ventilated about the Nexus between stake holders at the cost of poor patient. A large amount on treatment is towards medicines and that is where patient is hit hard because of so called "Brands". As per him outsourcing manufacturing is a fashion and practically all the pharma companies irrespective of their size , location and standing get their products manufactured from manufacturer thus quality is more or less same. Many companies who manufacture products for top 50 Indian and multinational pharma companies are located in SEZs in few States.

In 2016, the overall healthcare market in India was approximately $80 billion in size with medicines (which includes generics and branded) accounting for $16 billion, that is one fifth of the healthcare market.

About 60% of the healthcare spend is on delivery services such as hospitals and clinics. According to the WHO, India has 0.7 beds per 1,000 people, compared to 2.5 beds in China and 3.6 in Brazil. The inadequate services infrastructure leads to poor accessibility and availability of medicines. The government spend on healthcare (as percentage of GDP) is about 1% compared to 3-4% in most developing countries.

Our policy makers must understand that India is for all practical purposes a generics market — there are very few molecules that have patents with no competition and account for less than 5% in value terms. Each molecule is highly competitive with an average of 45-50 brands competing, ensuring that India remains one of the lowest cost Pharma markets. India is the third largest market globally by volume but the 13th largest in terms of value. In any case, over one-third of the domestic market is accounted for by National List of Essential Medicines drugs that are price-controlled by the government.

• Over 80% of the medicine purchases are out-of-pocket (and not through insurance)
• The doctor prescribes the brand (molecule or combination) that he/she believes will be the best for the patient. This leads to the patient buying the same from their local pharmacy retailer, creating a pull-factor for better brands.
• A forced move to genericisation will lead to a shift from pull-factor to push-factor, with the local pharmacy deciding which generic to sell to the patient.
• It is unlikely that the patient will benefit in terms of price reductions with the chemist pocketing the higher margins on the generics, given how the MRP fixation is currently done in India.

We would need every chemist shop to be manned by a pharmacist, at least a diploma holder. Where are we going to find 4 lakh pharmacists in India who would be interested in manning a chemist shop ?

Moreover, effective implementation of genericisation will require as many as 40,000 inspectors to oversee the functioning of over 4 lakh chemists, 40,000-plus stockists and distributors and over 4,000 manufacturing sites.

Our country is suffering from a lack of doctors and hospitals, and addressing these concerns will benefit the citizens much more rather than merely focusing on generics. The problem of affordability cannot be addressed without giving due importance to resolution of the other two malaises

1. Availability and
2. Accessibility that is afflicting Indian healthcare

Acording to an investment banker this move, though is a long term target it will require multiple steps including

• Strengthening the drug approval process,
• Strengthening the drug regulator,
• Increased inspection of drug facilities,
• Increased awareness of generic drugs and their quality and
• Rationalising the fixed dosage combination drugs.

The push to get the doctors to prescribe generic , is one of the many steps the government has been taking to reduce medical costs in India. The key ones has been

1. Expansion of National list of Essential Medicines (NLEM) bringing them under price cap,
2. Push by the government to increase awareness of generic drug prices and
3. Increase access through JAN AUSHADHI programme.

Industry associations who have reached out to the health ministry and hope to be able to approach the PMO to prevent the law from being passed, are opposed to proposal on the grounds that the onus of what patients should consume will shift from doctors to chemists. Chemists are unregulated and have no obligation, ethical or commercial, on what they sell patients, they have pointed out.

IMA has advised doctors that they can write the generic name and add the name of the company that manufactures the drug.Nobody can stop a doctor choosing the company for quality assurance.. IMA advised doctors to choose drugs from the National List of Essential Medicines (NLEM) as they are cheaper and of assured quality. When writing non-NLEM one can take consent. When prescribing one can write the cheapest available medicine and that will always be the generic version of that company. Meanwhile, doctors demanded that the Govt ban companies from manufacturing any generic medicine with a trade name and ensure they produced only high-quality generics.

The All India Drug Action Network (AIDAN), a civil society group working on drug pricing and accessibility pointed out that the proposal to make prescribing generics mandatory for doctors would be a useless, counterproductive step as a standalone measure. As in India no manufacturer markets medicines in the retail market under generic names and hence medicines are not available under generic names in the Indian retail pharmacy shops. AIDAN states that unless manufacturers (except those who are marketing medicines still under patent protection) are made to market medicines under generic names for the retail market, consumers would not get the benefit of "generic medicines

As per Mr SV Veeramani of IDMA , if doctors are made to prescribe only generics, the chemist might push medicines of companies that give him the highest margin, and there will be no accountability on quality.

We are trying to establish a US-based system for prescription in India, when we do not even have proper rules for quality check. How will it work ? Nearly 80% of the medicines sold in India are branded generics, and the entire drug industry has built its fortunes on this model.

Such policies might cripple the industry.

Courtesy:-

My thoughts together with inputs available in social media and secondary research