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