485Indian Journal of Clinical Practice, Vol. 23, No. 9 February 2013

Dr KK AggarwalPadma Shri and Dr BC Roy National AwardeeSr. Physician and Cardiologist, Moolchand Medcity, New DelhiPresident, Heart Care Foundation of IndiaGroupEditor-in-Chief,IJCPGroupandeMedinewSNational Vice President, Elect, IMAChairmanEthicalCommittee,DelhiMedicalCouncilDirector, IMA AKN Sinha Institute (08-09)Hony. Finance Secretary, IMA (07-08)Chairman, IMA AMS (06-07)President, Delhi Medical Association (05-06)emedinews@gmail.comhttp://twitter.com/DrKKAggarwalKrishan Kumar Aggarwal (Facebook)

from the desk of grouP edItor-In-ChIef

The Generic Drug Controversy

In his show Satyamev Jayate, Aamir 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 thecostofvariousbrands.Differentdivisionsof thesamecompany have brandswith different prices. This costdifference is even more evident in case of surgicalconsumables and devices.

Recently, Medical Council of India Code of Medical Ethics1.5issuedare-notificationandsaidthattherule1.5shouldbefollowedinitsspirit.Therulesays:

Medical Council of India Code of Medical ethics: 1.5UseofGenericnamesofdrugs:“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,whichwasattendedbyitsofficebearersalongwith the Drug Controller of Delhi, Director Health Services, President Gynecological Society of India, representatives from pharma industry and lawyers.

In this meeting, I discussed the Code of Ethics of MedicalCouncilof India1.5 interpretation in its letterand 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? Apparentlythefirstconcernwasmoreimportant.

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 aprescription.

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 may be a combination of 4-5 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 containsacrivastine8mg,paracetamol325mg,caffeine25 mg and phenylephedrine HCl 5 mg. In this case, a person has to write only the brand name without the generic constituents. Similarly, every multivitamin tablet inthemarketdiffersinthedoseofthevitaminsand other constituents. In Ayurveda, all drugs have over 10-40 ingredients for e.g. chyawanprash has over 40 constituents. Every brand of chyawanprash also differsinthedosesofeachconstituent.

The phrase “Prescribe drugs with Generic name”: Itis 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

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cost-benefit ratio to be decided on case-to-case basis.Prescribing costlier brands without justification or abrand 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.

Drugtermswerealsoelaboratedasunder:

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 canmanufactureandsellthiscompound.After20yearswhen the patent is over, the drug becomes a Generic drug.

Brand is thenamegivento themarketeddrugspecificto 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 theword “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.

Adrugcanbedispensedinthemarketasunder: Â 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 the 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 costdifference of all three varieties within the samecompany.

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 GN Singh, Drug Controller General of Delhi said that the intention of the government is that doctor

should write only chemical salt names. As per the new notification,theGovernmentisnotissuingnewlicensesfor 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 only the actual chemical name.

Dr NV 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 brandgivenadifferentname.DrRajinderSharmafromIMA compared it to a Kachori sold in Haldiram outlets, though it is sold in generic name but it is branded “Haldiram Kachori”.

Dr MC Gupta, Advocate said that doctors, hospitals and healthcare providers should follow the act and law in its spirit. Section 6 of the Consumer Protection Act (CPA) 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 3-4 brand names and let the patient choose which brand name he should get.

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 andfinaladvice.

It’s a medical fact that one should stick to a single brand as different brandsmay have different bioavailability.If the patient changes the brands too frequently, his chronicillnessmayhavefluctuationsinitsparameters.

Mr Rahul Gupta, Senior 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

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would include the cost of different brands also. If hewrites 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 National Accreditation Board for Hospitals and Healthcare Providers (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 thewords in thenotification“shall ensurethat 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 stocked by the chemist. One such example is famotidine.

Dr. VK Narang and Dr RN 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 nonpharmacist workers not capable of dispensing drugs in the interest of the patients.

Dr CM Bhagat said that drugs available only with the chemical salt name without a brand name are oftenpriced much higher than the branded drugs. Once the Government bans brand names, then 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,mosthospitalsoftenbuythecheapestbrands 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 such as sound-alike drugs and read-alike drugs.

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

Dr Nomita Gupta, Jt secretary IMA, Dr OP Sharma from Geriatric Society of India and Dr SC 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 DR 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. Oncethegovernment ispermittingaMRP tobe sold in themarket 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 majorcostdifferencesindifferentbrandsareincancerdrugs, biologics vaccines and endocrine drugs. Some vaccines are costlier in India and cheaper in the US. Therearemafiainmanystatesof thecountrywhodonot allow any other brand to be sold in that state.

Summing up the discussion, Dr VK Saini, Secretary General IMA said that IMA is concerned and is committed in providing cost-effective drugs to thepatient.IMAwantsaqualitysafedrugatacost-effectiveprice 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 websitewherecostsofallthebrandsarewritten.

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

 SincetherewasdifferenceofopinionbetweenIMAandDelhiHealthofficialsaboutthemeaningofthisstatement in the house, IMA will write to MCI for clarificationabouttheinterpretationofthisphrase.

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 Thephrase“PrescribedrugswithGenericname”:It is not the same as prescribing Generic drugs; it only means that the name of the chemical salt shouldalsobewritten.

 Whether you write a brand with a salt name or you write name of the salt 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.

 Mechanisms have to be evolved so that a quality, safe and affordable drug can be given tothe patient.

 One of the answers is price control on MRPs by the government.

 The IMA members should maintain the rational use of drugs while choosing a drug and ensure it qualifies the criteria: Quality safe drug and yetaffordable”.

 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.

 All doctors should write a salt name along with the name of the company or the brand name which is ofqualityandsafetyandyetcost-effective.

 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,properchecksandbalancesareessentialto 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 propermedicine.

 IMAfirmlybelieves that theGovt. should controlthe MRP of drugs, generic or branded so that benefitreachesthecommonman.

 The website of Central Drugs Standard Control Organization 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.

■ ■ ■ ■

Why the Word CPR 10? All my life, I have taught medicine in the form of formulas. The CPR 10 was created so that the public could remembertheprocessofcardiopulmonaryresuscitationorrevivalaftersuddencardiacdeath.

There is substantialevidence to suggest thatCPR iseffective in thefirst10minutesof cardiacarrest.After10minutes of death, there is practically no chance of recovery unless patient is in hypothermia.

There is also enough evidence that at least 10 minutes of cardiac massage should be given with a speed of 100 per minutes.

So,wecreateda formulaof10whichmeans that–within10minutesofdeath (earlier thebetter), at least forthenext10minutes(longerthebetter,upto25minutes),compressthecentreofthechestofthevictimwithaspeed of 10x10 i.e. 100 per minute.

Numerologically also, the CPR equates to number 10. In English alphabets, ‘C’ comes at number ‘3’, ‘P’ comes at number ‘16’ and ‘R’ comes at number ‘18’. If we add the three i.e. C=3, P=16, R=18 (3 + 16 + 18 = 37) and, if we furtheraddthetwodigitsin‘3+7’,thetotalwegetis‘10’.So,numerologically‘CPR10’shouldbeaneffectiveway to remember.