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Debate: Should hospitals ban Ranbaxy drugs?

In a virtual debate, AalaTimes presents the opinion of hospital administrator Dr S K Joshi and medico-legal consultant Dr M C Gupta on why hospitals should ban or not ban Ranbaxy Laboratories’ drugs. We also provide Ranbaxy’s official statement on the quality of their products.

Viewpoint: Yes, because Ranbaxy Laboratories sells adulterated drugs, commits fraud, felony — Dr S K Joshi

Dr S K Joshi

“Jaslok Hospital, Mumbai advises doctors not to prescribe medicines manufactured by Ranbaxy Laboratories”, the leading and one of the oldest drug firms in the country with an annual turnover of US $1,178 million. Reason — Recent conviction of the firm in the US for supply of adulterated drugs and submission of fraudulent data for approval of its drugs by the FDA, as admitted by the firm itself.

Not only the firm has been selling adulterated drugs (Pantoprazole and Atorvastatin) all these years but has been doing so knowingly and fraudulently like an incorrigible delinquent. They were warned by the US Food and Drug Administration (FDA) way back in 2006. And legal proceedings were started against them five years back. The firm has pleaded guilty to felony charges, admitting to selling adulterated drugs with intent to defraud, failing to report that its drugs failed to meet specifications and making intentionally false statements to the government and has been fined US $500 million for these offences.

What is surprising is that there has hardly been any murmur about it in India. Apart from Jaslok, no other hospital, no doctors, including IMA (Indian Medical Association), thought it fit to clamp an immediate ban on the company’s products. As for the silence and masterly inactivity of the Government, the CDSCO (Central Drugs Standard Control Organisation), and DCGI (Drugs Controller General of India) are concerned, the less said the better. Unlike other countries, the mission of the CDSCO, as per its status report, is “to meet the aspirations… demands and requirements of the pharmaceutical industry” and very faithfully, very honestly they have been doing that all this while — letting the drug firms — fake the data, market the drugs without any drug trials, and supply substandard, adulterated drugs.

Mass scale substandard manufacture, blatantly fake drug trials and data and supply of adulterated unsafe medicines all over the world must have done a lot of harm to the unsuspecting patients. They would have imperilled many lives. Think of the damage done to the prestige and reliability of the Indian Pharmaceutical industry. Reputation built over more than five decades, destroyed in one fell stroke. Nobody in the world (except the ignorant lot in India) will accept the Ranbaxy products any more. So far, only 2-3 drugs have been caught. But all the products, even those of other Indian companies, will have to go through the acid test to prove their quality. India is among the few developing countries that are exporting drugs all over the world. The loss of external markets means huge economic setback. It is not just a matter of poor quality, which can be condoned and forgotten. It is a naked expression of their greed, the criminal mindset and profiteering at the cost of human lives.

This is too serious a matter. Something has to be done and the medical profession has to take the lead. With the government in deep slumber, medical professionals are required to act as the guardians of patients’ interests, by completely boycotting the felons. The need of the hour is to act as catalysts and cause certain urgent and concrete measures that can have the desired cleansing effect:

First – Complete ban on all Ranbaxy products until quality standards in respect of each and every product are inspected, tested and proved beyond doubt and the company issues a public apology for its criminal activity. The ban cannot be imposed by the Govt. It has to be by the hospitals and the consumers. Doctors, practicing or in service, all have to join hands. This will also give them an opportunity to prove their concern for the patients. Forcing a ban on all the products will have an added advantage of forcing the company to expedite all the corrective measures. This will also convey to the world that we mean business.

Second – Criminal cases should be filed against Ranbaxy Laboratories for fraud, sale of adulterated drugs (under the Drugs and Cosmetics Act, 1940), as well as for breach of public trust. There is also a case for cancellation (at least suspension of manufacturing license) for the violation of GMP (good manufacturing practice) norms. It is not just a one time or first time accidental mistake. This firm appears to be a habitual offender. God knows how many more violations would be exposed if an independent enquiry is ordered. This will set a deterrent example for other defaulting drug firms who have not yet been exposed.

Third – Forcing the Govt to immediately initiate a judicial inquiry, as the IMA is planning, into the continuous defiance and violation of regulations by the Ranbaxy Laboratories.

Fourth – Immediate and major changes in the CDSCO as well as the DCGI organisations in view of the total failure of these two apex bodies in their tasks (with alarming magnitude of fake/substandard/adulterated drugs in the Indian market) and effective measures to restore some order.

This is also an opportunity for the pharma industry in the country to cleanse itself of the fake manufacturers and retrieve their prestige.

There is another reason why the medicos of the country should act now, unitedly and effectively, to eliminate the menace of adulterated drugs. Many of these drug felons have been thriving at the cost of doctors. Often, the doctors are blamed, manhandled or sued for complications or death/disability of their patients, in spite of the fact that their diagnosis was correct and they gave the patient the best possible advice and treatment. Little knowing that it was that wretched (fake/adulterated/substandard) drug that did the damage.

In view of the above, I feel that the medical professionals of India, regardless of their specialty, must understand the problem in its correct perspective and take every possible measure to guard the interests of their patients as well as themselves, from these unscrupulous drug manufactures. We owe it to the people of India.

Dr S K Joshi
MBBS, MHA, DNB, QMAHO, MAHA, MIPHA
Hospital Administrator,
Consultant Hospital Administration/ Quality Management in Healthcare
Assessor for NABH Accreditation of Hospitals
Visiting Faculty for PG Courses in Hospital/ Health Management
Author of Books: ‘Quality Management in Hospitals’
‘Law and The Practice of Medicine’
‘Safety Management in Hospitals’

Counterview: No, we should not take law in our own hands but make appropriate complaint to the concerned authorities! — Dr M C Gupta

Dr M C Gupta

To me, the issue appears to be a complete non-issue. The questions that stare in the face are:

–Ban whom?
–Ban from doing what?
–Ban under what authority?

In response to the above questions, it is very clear that the hospitals have no authority to ban anybody from doing anything. It is true that they can ban themselves from doing anything they feel like. But that is hardly the concept of banning.

Let me explain further by making some definitive statements as follows:

1—Hospitals are free not to buy Ranbaxy drugs for the purpose of administration to indoor patients who have to be given their daily dose of the medicine by the nursing staff and attendants etc. If this is the concept of banning, it is clear that I have nothing against it. As buyers of medicines, hospitals have full liberty to buy or not buy drugs from a particular company. The only problem is that there may be some odd drug, which is needed by a patient but marketed by Ranbaxy and no substitute is available. In such a situation, I am afraid the hospitals would have to relax their “ban” in the interest of the patient.

2—Hospitals are not free to “ban” Ranbaxy drugs as regards giving a prescription to the patient. The question of prescribing drugs marketed by Ranbaxy or any other company just does not arise in view of the existing ban on prescribing drugs by trade names by virtue of Regulation 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, reproduced below:

“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.”

It is clear that physicians should prescribe a drug by its generic name and not by its brand name. In the circumstances, the question of banning hospital doctors from prescribing Ranbaxy drugs just does not arise.

3—Some hospitals maintain a pharmacy or drug shop within the hospital from where people can buy drugs prescribed by a doctor. If the hospital bans the pharmacy / drug shop from storing or selling Ranbaxy drugs, such an act will be patently illegal and challengeable in the following ways:

i)—The owner of the shop would be within his rights to sue the hospital for breaching the contract under which the shop was established.

ii)—Any consumer or potential consumer (member of the general public) would be within his rights to sue the hospital as well as the shop for violation of his consumer right as regards choice from a variety of goods in terms of section 6(c) of the Consumer Protection Act, 1986.

4—Let us also consider what might be the purpose or justification of such a “ban”.

If it is thought that something wrong is being done by Ranbaxy Laboratories by way of selling drugs that are substandard or spurious or otherwise defective, the proper way is not to take law in one’s own hands but to make appropriate complaint in this regard to the concerned authorities under the laws applicable. For example, action can be taken under the Drugs and Cosmetics Act, 1940; Indian Penal Code (IPC), 1860; or Consumer Protection Act, 1986 as well as through other legal mechanisms available.

5—Finally, let me gently remind the apparently overactive and overzealous hospitals talking of a ban that there are much more mundane things at their own doorstep that they may like to ban and for which everybody would be grateful to them. As a matter of fact, corporate hospitals would be doing much good to themselves and to the public by ensuring that they themselves do not violate laws rather than telling others not to do so. The examples of illegalities committed by hospitals are quite a few. The long lists of cases against the hospitals in consumer courts bear testimony to the fact that there is a big stable to be cleaned.

Dr M C Gupta
Advocate & Medico-Legal Consultant
MBBS [AIIMS]
MD, Medicine, [AIIMS]
MPH [San Carlos University, Guatemala, Central America]
Post-Doctoral Fellow [United Nations University]
LLB [Delhi University]
LLM [Kurukshetra University]
Member, Indian Law Institute
Member, Supreme Court Bar Association
Fellow, National Foundation of Clinical Forensic Medicine
mcgupta44@gmail.com
http://in.groups.yahoo.com/group/medico-legal-queries
medico-legal-queries@yahoogroups.co.in
Formerly: Professor & Dean, National Institute of Health & Family Welfare
Additional Professor, All India Institute of Medical Sciences (AIIMS), New Delhi

And here is what Ranbaxy has to say:

All Ranbaxy products currently in the Indian market and globally are safe and efficacious. Ranbaxy stands by the quality of every medicine that the company makes and distributes in India and every country around the world.

“Ranbaxy operates cGMP (Current Good Manufacturing Practice) compliant manufacturing facilities in India and several other countries across the globe. The company’s India facilities are routinely inspected by the Drug Controller General of India (DCGI) and many other leading global regulatory agencies.

“Ranbaxy remains committed to its philosophy of ‘Quality and Patients First,” Ranbaxy spokesperson said on Friday in an advisory issued in public interest for patients, doctors and all its stakeholders.

Related Stories

IMA plans to ask DCGI to probe quality of Ranbaxy’s drugs

Jaslok Hospital advises doctors against prescribing Ranbaxy drugs

Ranbaxy to pay $500 million to settle US fraud charges

6 Comments

  1. Dr Subodh Kumar Singh Dr Subodh Kumar Singh Tuesday, June 4, 2013

    Reply to Dr S K Joshi’s answer,
    Dear Dr Joshi,
    1.Nation,doctors and patients will be served better if an agency gives its report on the quality and quantity of the drugs being marketed in India, on a regular basis. Doctors would be able to prescribe cheapest brand with highest confidence, and patient will receive maximum benefit spending least money and even generic medicines will be prescribed more.
    2. If the offences were made out in India,why are indian law enforcing agencies sleeping? And even after the US conviction, why they did not wake up from their sleep? Is the onus of taking action against an erring company with criminal actions of producing substandard medicines and fake data-to teach a lesson and cleanse the system- is on doctors and hospitals in India? I am sure no offence has been made out in India.There is no proof that they committed the same crime in India and there is no complain either. So, I am concerned with your presumption.
    3.And, thanks for agreeing to my impression about DCGI and CDSCO.
    4.These “Ban” actions are too symbolic to have any practical value and are taken and promoted by true publicity seekers. Real action takers will go to police or court to take action against the company.

    Regards,

    Dr subodh Kumar Singh

  2. m c gupta m c gupta Sunday, June 2, 2013

    What I had to say I have said for the purpose I said. I need not repeat it.

    Just a few additional comments:

    We are simply talking in the air. The “banning” of Ranbaxy drugs by hospitals is a non-starter. I know it through experience. I deal with medico-legal issues and keep on advising the medical profession about their legal rights and about the ways to fight injustice. They are least bothered or interested or willing to fight. “They” includes, quite often, even the IMA.

    Why debate about a thing which (the ban) does not exist and is never going to be there?

    I will wait for the day when such a ban is implemented (not merely announced) even in 5 hospitals in India.

    –M C Gupta

  3. Dr S K Joshi Dr S K Joshi Sunday, June 2, 2013

    Answer to points raised by Dr Subodh Kumar Singh :
    Dear Doctor Singh,
    1. Your contention is not right. The boycott or ban of Ranbaxy drugs is aimed solely at improving the quality of drugs which are used exclusively by the patients. Patients’ interest is at the centre of the debate.
    2. Ranbaxy may not be the only culprit. But it may be the starting point to clean the muck.
    3. You are wrong again in your statement -“although no offence made out in India”
    These offences were all committed in the factories located in India where the alleged fake research data were generated and adulterated medicines were manufactured. These same medicines would be for sale in India as well and used by many Indian patients. The pity is that during seven years that the Americans pursued the matter, DCGI and the CDSCO in India did not take any action against the firm.

    Dr S K Joshi

  4. Dr Naresh Bansal Dr Naresh Bansal Saturday, June 1, 2013

    When DGCI and CDSCO are not able to control quality of branded drugs , how can they assure us abour generic drugs??

  5. Dr Subodh Kumar Singh Dr Subodh Kumar Singh Saturday, June 1, 2013

    Interesting debate- for the sake of it. None is interested in patient’s interest or welfare. The whole debate , opinions in public and “bans” seem to be based on the presumption that Ranbaxy is the only culprit ( although no offence made out in India) and all other companies are providing highest quality drugs in India and are following current Good Manufacturing Practices and DCGI very honestly inspects them. It all seems “too academic” to have any practical value.

  6. Dr S K Joshi Dr S K Joshi Saturday, June 1, 2013

    COUNTERPOINTS TO DR M C GUPTA’S VIEWPOINT
    1. Banning who, for doing what, under what authority ?
    Counterpoint : Banning or boycotting the Ranbaxy Products by the doctors/ hospitals/ nursing homes. For that no authority is needed from anyone.
    2. Question of Ban by hospitals does not arise in view of the existing ban on prescribing drugs by trade names vide IMC regulations 2002.
    Counterpoint : IMC Regulations have hardly been effective all these years. Those actively involved with patient care and issue/dispending of medicines would agree that still the drugs are being prescribed largely by trade names and not by generic names.
    3. Some hospitals maintain Pharmacy………….
    Counterpoint : During my experience as a hospital administrator I have seen that When the hospital management advises the in-house Chemist shop not to issue particular drugs ( on grounds of adulteration/ poor quality) to the hospital patients, generally chemist abides by the instructions. To the outsider customers, or even some odd hospital patient who insists on a particular brand, however, he may issue the drugs with a cautionary advice. As far as his stocking the Ranbaxy drugs is concerned, there can be no embargo on that, unless the drugs are banned by the Govt. authorities.
    Customer suing the hospital for not prescribing /issuing Ranbaxy drugs is a totally baseless point. No patient would go against the advice ( in his own best interest ) of his treating physician, leave aside suing the physician or the hospital on this score.
    4. The proper way is not to take law in one’s own hands but to make appropriate complaint in this regard to the concerned authorities under the laws applicable.

    Counterpoint : Using or not using/Boycotting a particular firms’s products on grounds of adulteration/poor quality is entirely the prerogative of the hospital or the treating physician. It does not mean taking the law in one’s own hands or violating any law.

    As regards complaining to the appropriate authorities, the offences committed by the drug firm are in public knowledge already and the authorities concerned like DCGI are well aware. They don’t need any formal complaint. In fact it is their failure to take action against the firm, that should prompt the medical profession to raise their voice and wake up the authorities to take action.
    5. Violation of laws by hospital’s themselves…….. :
    Counterpoint : Violation of any law by a doctor or a hospital does not absolve the felon drug firm from its crime nor does it protect the firm from the legal consequences of its acts of commission.

    COUNTERPOINTS TO STATEMENT BY RANBAXY LABORATORIES

    1. All Ranbaxy products currently in the Indian market and globally are safe and efficacious.

    Counterpoint : They may be right. They may be wrong. Before this case of Pentoprazole and Atovastatin, public had reposed full faith in them which has now been shaken. If they want to regain the public trust, they will have to do better clean their tainted image.

    2. Claim about compliance with GMP norms and inspections by DCGI and other global regulatory agencies

    Counterpoint : All their claim about compliance with GMP norms and inspections by DCGI and other global regulatory agencies, is belied by their own admission of felony charges in the US court, for selling adulterated drugs and ( knowingly) generating and submitting fake data with the intention to defraud. When the intentions become suspect, it becomes very difficult to defend.

    –Dr S K Joshi

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