The generic drug controversy

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In his show Satyamev Jayate, Amir Khan had asked doctors across the country to not write brand names and instead write only the generic chemical names of the drugs. This generated a lot of controversy in the country. The reason was a huge difference in the cost of various brands. Different divisions of the same company have brands with different prices. This cost difference is even more evident in case of surgical consumables and devices.

Recently, Medical Council of India Code of Medical Ethics 1.5 issued a re-notification and said that the rule 1.5 should be followed in its spirit. The rule says:

Medical Council of India Code of Medical ethics: 1.5 Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with generic names and he / she shall ensure that there is a rational prescription and use of drugs.

The Indian Medical Association recently held a meeting which was attended by its office bearers along with the Drug Controller of Delhi, Director Health Services, President Gynecological Society of India, representatives from pharma industry and lawyers.

Dr K K Aggarwal National Vice President Elect IMA discussed the Code of Ethics of Medical Council of India 1.5 interpretation in its letter and spirit.

What was the intention of the MCI when the regulation was made? Was it the rational use of drugs with concern on quality and safety or to provide cheaper drugs? Apparently the first concern was more important.

In MCI regulations, the phrase “Use of GENERIC NAMES OF DRUGS” does not talk about using GENERIC DRUGS. The word ‘generic name’ means the CHEMICAL NAME. It is called INN or International Proprietary Name. For example, for aspirin, it is Acetyl Salicylic Acid.

The phrase “Every physician should” makes it binding. The only interpretation one can take from this is that the name of the chemical salt SHOULD be written in a prescription.

The phrase “As far as possible” means that there will be situations where a person may not be able to write the name of the salt. For example, the name of the salt may be too long to write like ‘Monosorbide nitrate’ or the drug is a combination of four or five drugs and in emergency, it may not be possible to write the chemical name of all the drugs. In that case, not writing chemical name would come under the exception “as far as possible”.

Another example is the drug NASOREST PLUS which contains acrivastine 8 mg, paracetamol 325 mg, caffeine 25 mg and phenyl ephedrine HCL 5 mg. In this case a person has to write only the brand name without the generic constituents. Similarly every multivitamin tablet in the market differs in the dose of the vitamins and other constituents. In Ayurveda all drugs have over 10-4- ingredients and doses, for e.g. chyawanprash has over 40 constituents. Every brand differs in the doses of each constituent.

The phrase “Prescribe drugs WITH GENERIC NAME”: It is not the same as prescribing GENERIC DRUGS, it only means that name of the chemical salt should also be written.

The phrase “Shall ensure that there is a rational prescription” means that prescription of drugs should be evidence based and/or with informed consent. It would also include that one should justify the cost benefit ratio to be decided on case to case basis. Prescribing costlier brands without justification or a brand only from a particular chemist would amount to unethical act under this.

The phrase “And use of drugs” means the above is applicable for dispensing practice also.

Drug terms were also elaborated as under:

PATENT drug means a drug belonging to the original innovator company, which has researched the molecule. The company gets the right to sell this drug exclusively for 20 years and during this period no other company can manufacture and sell this compound. After two years when the patent is over, the drug becomes a GENERIC DRUG.

BRAND is the name given to the marketed drug specific to a company for selling. Both patented drugs and generic drugs can be sold under a brand name. Brand names are usually so named that the doctor can easily remember the chemical constitution or its action or the disease in which it has to be used. It is usually a shortcut so that it is easy to remember. For example ‘Ramipril” is chemical salt and most brands will have the word “ace” as a prefix or suffix, for e.g. HOPace, CARDace, RAMace etc reminding the doctor that it is an ACE inhibitor.

GENERIC NAME means the name of the chemical salt and is not synonymous with a generic drug.

A drug can be dispensed in the market as under:

  • The name of the generic salt with no brand name: For e.g., Dr Reddy’s Amlodipine or Zydus Amlodipine. In both the situations, the company’s name becomes a brand. It is available at the cheapest price as there is no marketing cost.
  • Unpopular brand: It is usually pitched for a bulk supply in any institution. It is costlier than company branded generic salt but cheaper than the popular branded drug.
  • Popular brand: It is marketed for the individual doctor’s use in a chemist shop and is the costliest.

The company may market all three products under different divisions and there may be a huge cost difference of all three varieties within the same company.

Mr. Atul Gandotra representing the pharma industry said that in India all the drugs are generic drugs, as India hardly has a patent for any drug in the world.

Dr G N Singh, Drug Controller of Delhi said that the intention of the government is that doctor should write only chemical salt names. As per the new notification, the Government is not issuing new licenses for any brand names. License is being issued only for the chemical name of the salt.  He also said that Under the Drug and Cosmetic Act 1965 11A, a brand name cannot be substituted by the chemist. Government wants that a doctor should not write the chemical salt along with brand name, they will have to write actual chemical name only.

Dr N V Kamath, Director, Health Services said that Delhi Government since 1994 has made sure that Delhi Government hospitals only buy drugs with chemical names. No branded drugs are bought. But Delhi Government buys the generic name drugs only from reputed branded companies.

The house however felt that the word ‘reputed branded company’ in this situation becomes a brand. A generic salt name by a branded company is nothing but a brand given a different name. Dr. Rajinder Sharma from IMA compared it to a Kachori sold in Haldiram outlets, though it is sold in generic name but it is branded “Haldiram Kachori”.

Dr. M C Gupta Advocate said that doctors, hospitals and health care providers should follow the act and law in its spirit. Section 6 of the Consumer Protection Act talks about the rights of the Consumers and it mentions that a consumer has a right to choose the medicine. Informed choice is fundamental principle of the Consumer Protection Act. Every doctor should write the name of the salt along with three to four brand names and let the patient choose which brand name to have.

But the house felt that doctors may be under the purview of the CPA but their relationship is beyond CPA. Patients go to a shop to choose a product and do not expect the shop owner to decide for them which brand they should buy. But a patient comes to doctor with an expectation that the doctor would be taking decision on his behalf. If doctors start giving options for everything the patient will get confused. It is the job of a doctor to give choices as well as his decisions and final advice.

It’s a medical fact that one should stick to a single brand as different brands may have different bioavailability. If the patient changes the brands too frequently, his chronic illness may have fluctuations in its parameters.

Mr. Rahul Gupta Sr. Advocate High Court and Supreme Court said that the interpretation of the MCI clause unless amended does not force a doctor not to write a brand name. But when choosing a brand the doctors should follow the rational prescription that would include the cost of different brands also. If he writes a particular brand if questioned he should be able to justify the reason of his or choice in the court of law. It’s the duty of the doctor to know what he is writing.

Mr. Girdhar J Giani, formerly at NABH said that according to him the law does not restrict doctors from writing the brand name but one should write the name of the chemical salt in bracket. He added that the words in the notification “shall ensure that there is a rational prescription and use of drugs” will cover the factor of unnecessary high cost. “If a doctor is purposefully prescribing a drug available in a particular chemist shop having rates which is higher than other standard drugs, it will be an unethical practice under the above section” said Mr Giani.

Regarding his views, the house felt that if doctors have to write only chemical names then the Government should ban all the branded drugs because if this is not done, then the uneducated chemists decide which brand to give. As of today, no doctors are informed about all the brands available and their prices and every chemist does not keep all the brands. Most of the drugs which are cheaper are not kept by the chemist. One such example is famotidine.

Dr. V K Narang and Dr R N Tandon (JS IMAAMS), from IMA said that the law does not permit a chemist to replace one brand with another. Most chemist shops are run by uneducated non pharmacist workers not capable of dispensing drugs in the interest of the patients.

Dr. C M Bhagat said that drugs available only with the chemical salt name without a brand name are often priced much higher than the branded drugs. Once the Government bans brand names then the name of the company which is making the generic drug will become a brand. Every doctor instead of writing Stamlo will start writing Dr. Reddy’s Amlodipine. MCI does not cover hospitals and doctors working in a hospital have to write a brand drug, which is available in their pharmacy. Also most hospitals often buy the cheapest brands and sell them at the highest rates.

Dr. Harish Grover, Past Secretary General, IMA said that it is true that every drug which is approved by Drug Controller of India is a quality drug with near similar bioavailability but giving a free choice to chemist to choose the drug will be a disaster. He said that the purpose of writing chemical name along with brand was to reduce prescription errors – like sound-alike drugs and read-alike drugs.

If the intention of the MCI is not to write brands then the research in pharmaceutical industry will be over. The same chemical salt because of the research is marketed as quick acting drug, OD drug, Nano particle formulation, in controlled release tablet, continuous release technology, slow release tablet etc. Every company has designer brands with different formulations to affect the quick of delayed bioavailability of the drug.

Dr. Nomita Gupta Jt secretary IMA, Dr. O.P. Sharma from Geriatric Society of India and Dr. S C Pandey Governing Council Member IMA re-emphasized that banning brands is not the answer as the company name with the generic salt will then become a brand. The President Gynecological Society of India said that if you allow the chemist to choose the drug he will never give the cheapest brand as his interest would be his margin.

Dr. D. R Rai, Senior Vice President, IMA, warned against the chemist who exploits about all the drugs and he said if government is so concerned about the prices of a drug, they can control the price of the same. It is the government who decides about the price. It’s the government who fixes the MRP of a drug. Once the government is permitting a MRP to be sold in the market they cannot ask the doctors to not write drugs at that MRP. If the government is so concerned about prices, they should limit the cost of any medicine.

Dr. Ajay Gambhir Finance Secretary IMA said that all licensed drugs may be good but may vary in post marketing surveillance results. He further said that major cost differences in different brands are in cancer drugs, biologics vaccines and endocrine drugs. Some vaccines are costlier in India and cheaper in the US. There are mafia in many states of the country who do not allow any other brand to be sold in that state.

summing up the discussion, Dr. V K Saini, Secretary General IMA said that IMA is concerned and is committed in providing cost effective drugs to the patient.  IMA wants a quality safe drug at a cost effective price to the patient. He said 70% of the expense of a treatment is on drugs; therefore, Government should evolve a mechanism to reduce the cost of drugs to the patient. The government should also come out with website where costs of all the brands are written.

The meeting concluded with the following points by Dr Narender Saini Secretary General IMA

  1. Since there was difference of opinion between IMA and Delhi Health officials about the meaning of this statement in the house. IMA will write to MCI for clarification about the interpretation of this phrase.
  2. The phrase “Prescribe drugs WITH GENERIC NAME”: It is not the same as prescribing GENERIC DRUGS; it only means that the name of the chemical salt should also be written.
  3. Whether you write a brand with a salt name or you write a salt name with name of the pharmaceutical company, it is the same.  In one the company derived name of the salt becomes a salt and in the other, the salt linked to a company becomes a brand.
  4. Mechanisms have to be evolved so that a quality, safe and affordable drug can be given to the patient.
  5. One of the answers is price control on MRPs by the government.
  6. The IMA members should maintain the rational use of drugs while choosing a drug and ensure it qualifies the criteria: quality safe drug and yet affordable”.
  7. The so-called nexus between doctor and chemist or a pharma company, where a doctor is writing a particular brand, a costly brand or a brand only available with particular chemists should be considered unethical.
  8. All doctors should write a salt name along with the name of the company or the brand name which is of quality and safety and yet cost effective.
  9. Since in our country, patients have very limited access about the information of drugs and even persons employed in chemist shops are also not qualified, proper checks and balances are essential to  ensure that patients get the best medicine on physician prescription. Doctors along with Govt. machinery and price control are the only mechanisms to ensure patient getting proper medicine.
  10. IMA firmly believes that the Govt. should control the MRP of drugs, generic or branded so that benefit reaches the common man.
  11. The web site of Drug Controller should mention the name and addresses of manufacturing and marketing companies authorized by them to ensure the traceability of the product. It should also mention the MRP of drugs.