Last month, the healthcare industry was stunned by the news of settlement between one of the world’s largest generic drug manufacturers, Ranbaxy Laboratories and the US FDA. Pleading guilty to seven federal criminal charges related to faulty drug manufacturing dating back to 2008, Ranbaxy agreed to pay US regulators $500 million as a fine.
A lot has been said about the judgment and its repercussion since then. Immediately after the verdict, experts opined that the incident may reflect badly on the generic drugs manufactured in other parts of the country. Some hospitals released advisories against prescribing Ranbaxy drugs. Yet, what has not been commented on is the fact that whether small or big, any fraud is a fraud. All pharma companies are expected to operate under Current Good Manufacturing Practices (cGMP). Violating the trust of patients and not following cGMP is not acceptable.
According to a US Department of Justice (US DOJ) press release dated May 13, Ranbaxy admitted to selling certain batches of adulterated drugs that were produced at Paonta Sahib in 2005 and 2006, including sotret, gabapentin, and ciprofloxacin. The company also acknowledged that the FDA’s 2006 and 2008 inspections of the Dewas facility found the same issues with incomplete testing records and an inadequate stability programme, as well as significant cGMP deviations in the manufacture of certain active pharma ingredients and finished products.
Secondly, we need to question the quality of drugs the company sold in India at the same time. How can we be sure that the drugs that were sold in India were not adulterated and substandard as in the US?
Thirdly, the incident was brought to light by a whistleblower – a former employee. Had he not implicated the company no one would ever know of the fraud. Doesn’t that imply that local standards of the drugs may not be up to the mark and local consumers are exposed to sub-standard products? And we have no way of knowing if this was happening.
And lastly, the US DOJ release further states that the company has admitted to making false, fictitious, and fraudulent statements to the FDA in Annual Reports filed in 2006 and 2007 regarding the dates of stability tests conducted on certain batches of Cefaclor, Cefadroxil, Amoxicillin, amoxicillin and clavulanate potassium, which were manufactured at the Dewas facility.
Regulators as such do not test drugs. They rely on the companies to be ethical and stick to the manufacturing guidelines and make sure that a drug meets the requirements of safety, identity and strength, and meets the quality and purity characteristics, which the drug purports or is represented to possess. How do we know that Ranbaxy has not jeopardised our faith? This incident has raised serious concerns about the quality of the company’s other drugs and whether we are safe.
We spoke to a number of eminent doctors in India about their views on the above. Many raised similar concerns but did not want to comment openly. We are publishing a few who did come forward to talk about it.
Dr BS Ajaikumar, Founder & Chairman of HCG, Bangalore
Menace of spurious/adulterated drug is on increase. When companies sell adulterated drugs, they cause patients to take drugs that are substandard, ineffective, or unsafe and sometimes cause irreversible problems, even death. It is very sad that large drug manufacturers are involved in such frauds. We do not use drugs manufactured by the said company.
Dr KK Aggarwal, Consultant, Medicine and Cardiology, Moolchand Medcity, New Delhi
Indian pharma industry is one of the top three growing industries of the world, it is expected to reach $20 billion by 2015. The domestic industry players have a major role in ensuring safety and quality and providing drugs at affordable prices. ‘Counterfeit drug’ is one which is deliberately and fraudulently mislabeled with respect to identity and/or source, as per WHO. Counterfeiting can apply to both branded and generic drug products. Counterfeit medicines may include products with the correct therapeutically active ingredients but fake packaging; with the wrong ingredients; without active ingredients or with insufficient active ingredients.
In developing countries, drugs used to treat life threatening conditions such as malaria, tuberculosis and HIV/AIDS are generally counterfeited. It is the responsibility of every healthcare provider to ensure that the quality and safety of medicines are not compromised. Spurious drugs can take lives and it is the duty of the enforcing agencies to look into that. Whenever a person is not responding to a drug one should suspect a spurious drug. Stringent prompt time bound action should be taken in this aspect.
(When asked about the doubt on the quality of drugs manufactured by Ranbaxy)
I think it is a knee jerk reaction by Jaslok Hospital. The advisory should come from the Drug Controller Department or the Medical Council of India. Individual hospitals cannot follow that stand. If that was true the drug controller department by now should have come with their advisory.
Dr Anil Kumar HOD Surgery, Head-Pharmacy & Therapeutic Committee Bangalore Baptist Hospital
Spurious drugs are dangerous to the patients who have a false security of taking drugs and thinking their disease is under control. It can be life threatening in ICU patients. Many companies outsource the manufacturer, procure it and then market it. Standards at manufacturing site is questionable. Same might have happened with Ranbaxy. All of us are under Drug Controller of India/regional areas.
It is the responsibility of the Drug Controller to check the quality and inform to medical fraternity and withdraw the drug from market. Also the hospitals have to inform the Drug Controller if they have doubt about the quality. As far as our hospital is concerned, we follow the Drug Controller’s instructions. The incident is an eye opener for the Drug Controller and hospitals to be aware of such a possibility.
Dr Prashant Kulshrestha Unit Director, Rockland Hospital, Manesar
As of now we are using branded products but we have definite plans to move towards having generic products. This will be of immense importance for Rockland Manesar as cost control and thereby service offering at competitive rates will always remain an area of importance. Instead of trying to reinvent the wheel our simple approach is that we go for compiling the list of generic (unbranded) products of lead manufacturers.
In this endeavour we have chosen Dr Reddy’s Pharma Labs (which is among top 10 generic product companies of the world). It is an Indian pharma giant and has got fair understanding of the market and its needs. It produces over 400 products covering all major speciality and super specialty in practice at our Rockland Hospital, Manesar. We also look ahead to involve other players like Sanofi (France), Sandoz (Germany) who have prevailing markets in India and are known for their quality.
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