Ranbaxy Case Study
Ranbaxy Case Study
Ranbaxy Case Study
Vinti Agarwal
BBC Media Action
Omprakash Gupta
University of Houston Downtown, USA
Keren Priyadarshini
Truven Healthcare
ISBN: 978-1-943295-08-1
Shubham Agrawal
Credit Suizze
Ranbaxy Laboratories Ltd., based in India, with sales both in India and abroad, yet ironically was pulled up for
violations from GMP only by the United States Federal Drug Administration (USFDA). Records of any active
regulatory diligence by Indian pharma regulators that may have prevented the slide of this once internationally
reputed company seems unavailable. International investigations on Ranbaxy has inevitably led to questions also
being raised on the safety and manufacturing processes and practices of the entire Indian pharmaceutical industry.
While the case study dwell on lapses by Ranbaxy Laboratories, it is in parallel a critique on regulatory lapses of
Indian pharmaceutical regulators.
1. Introduction
In 2014, when Sun Pharma acquired 64% of Ranbaxy Laboratories from Daiichi Sankyo for$3.2 billion, it would be the
second time the company has changed hands in 6 years (Malhotra, 2014). The earlier acquisition of Ranbaxy by Daichi
Sankyo in June 2008 from the original promoter family, had got mired in a series of controversies regarding diligence
disclosures by the promoters. This has led to an arbitration court in Singapore levying a fine of $525 million on former
shareholders of India‘s Ranbaxy Laboratories for concealing the severity of its regulatory issues with United States Federal
Drug Administration (USFDA)
The first wave of serious trouble hit Ranbaxy in the year 2008 when the FDA suspended importation of more than 30
products from Ranbaxy Laboratories Ltd after discovering manufacturing and quality violations that were revealed by a
whistle blower in 2007(Associated Press, 2013). Consequently in 2011, FDA struck a deal with Ranbaxy that required the
company to ensure that data on its products was accurate. It was also required to undergo extra oversight from a third-party
and improve its drug making procedures. From then onwards, the company went rapidly downhill, so much so that even a
visit to the website of the Sun Pharma will show no milestones listed against Ranbaxy post 2012. Finally in 2013, Ranbaxy
Laboratories Limited agreed to plead guilty to criminal charges and admitted as part of the deal that it sold impure drugs
developed at two manufacturing sites in India. A once admired company had fallen into disrepute. But the signs of
misdemeanor were evident from the year 2002 onwards itself.
Ironically before the highlighting of quality lapses in 2008 onwards, Ranbaxy was regarded as one of the leading
pharmaceutical companies in the world. With a revenue of US $ 260 million in 2006 and a share of 5.1% in the domestic
market, Ranbaxy Laboratories Ltd. was India‘s largest pharmaceutical company. It‘s international sales at that time was $ 1.3
billion and was one of the largest ANDA (Abbreviated New Drug Application) filers with US FDA (United States Food and
Drug Administration). The company‘s offices were spread over 49 countries with approximate employment strength of
12,000. (Bhatt P. R.) Not only was it one of the ten largest generic drug manufactures in the country, it also had a strongly
international focus with three-fourth of Ranbaxy‘s revenue coming from international sales, with the US alone accounting for
almost one third(Bhatt P. R.).
The transition from a leading company to one that is mired in controversy has entirely come about through investigations
by USFDA into Ranbaxy‘s operations initiated largely through Dinesh Thakur, an employee of Ranbaxy later turned
whistleblower. He found that the generic drugs that were made by Ranbaxy used bioequivalence data that either did not exist
or was made up. The Indian regulators virtually sat through the entire process with no independent investigations into
Ranbaxy‘s manufacturing processes. Given that Ranbaxy had a huge domestic market, this constituted a serious dereliction of
regulatory oversight by Indian pharma regulators. Very recently, Dinesh Thakur has filed a Public Interest Litigation (PIL )
against Indian drug regulators accusing them of failure to enforce safety standards in the $ 15 billion domestic drug industry.
In his filing, Thakur has also cited the case of CDSCO allowing UCB to sell Buclizine (later marketed by Mankind
Pharma) as an appetite stimulant in 2006 even though it was not approved for that purpose in Belgium and moreover banned
in several other countries. Neither UCB nor later Mankind Pharma was asked to conduct clinical studies on the efficacy of the
drug even though the drug was still being sold in the market. Apparently, despite a demand for an enquiry into the same by a
parliamentary committee in 2013, Reuters at the time of going into print has not received any intimation of any initiation of
any enquiry.
Fifteenth AIMS International Conference on Management 127
The fall from grace of a once reputed company might primarily be blamed on management of the company but it somewhat
also puts Indian drug regulators in the dock for turning a blind eye to violations by the company. It also brings into question
why regulators in India did not move fast enough to take matters into their hand once violations were discovered. Throughout
the USFDA investigations into the affairs of Ranbaxy, there was virtually no parallel inquiry that was conducted at the end o f
Indian regulators even though the process was long drawn out and was in the public domain. Only as late as 2014, when
Ranbaxy was final banned, did Indian regulators sit up and take notice, but hid under the excuse that they neither had the
resources & infrastructure nor the standards commensurate with the USFDA to do a similar level of stringent vetting. (Dey,
2014)
1. HISTORY OF RANBAXY
1937-1968: Origins
Ranbaxy, was founded in Amritsar in 1937 as a distributor company distributing vitamins and anti-tuberculosis drugs for a
Japanese pharmaceutical company by Ranjit Singh and Dr Gurbax Singh. The company was bought by Bhai Mohan Singh
from his cousins thereafter. It ventured into a distribution alliance with an Italian company Lapetit in 1951. It‘s manufacturing
venture began with technical assistance from Lapet it for some limited local manufacture in 1961. The association with
Lapetit ended in 1966, with Ranbaxy making a decision to get into more local formulations and also into reverse engineering
of drugs (Sundar). Ranbaxy tasted success for the first time in the 1960s with a drug marketed under the name of ‗Calmpose‘,
a tranquilizer made from diazepam imported from a supplier in Soviet Bloc. Incidentally, diazepam, was owned by Roche but
it hadn't sought patent protection for it in India. Calm pose went on to become India's first pharmaceutical super-brand
(Bhandari, 2014).
on the AIP meant it was now the onus of the company to prove that its drugs were of quality and that it was no longer the
FDA that had to look at Ranbaxy‘s data to prove the drugs didn‘t make the grade. The AIP covered all products
manufactured at Ranbaxy‘s facility at Paonta Sahib, Himachal Pradesh. In August 2011, Ranbaxy also closed the unit located
at Gloversville, NY, USA.
With FDA putting Ranbaxy on watch, Daiichi Sankyo also proceeded to initiate legal proceedings against the the former
promoters of India‘s biggest drug maker Ranbaxy Laboratories Limited — Malvinder Singh and family for concealing and
misrepresenting critical information.
This turbulence in Ranbaxy was also reflected in its leadership changes. The CEO of the firm, Mr. D.S. Brar stepped down
in June 2004 following differences with the family. This was followed by a series of leadership changes beginning from Mr.
Brian Tempest (July 2004-December 2005), Malvinder Singh (January 2006-May 2009), Atul Sobti (June 2009- August
2010) and finally Mr. Arun Sawhney (September 2010-October 2015). Finally, in April 2014, Sun Pharmaceutical Industries
Ltd announced the acquisition of Ranbaxy Laboratories Ltd in an all–stock transaction.
The Sun Pharmaceutical Industries‘ $3.2-billion all-share acquisition of Ranbaxy created not only India's largest
pharmaceutical company but also a significant global supplier of generic medicine. The biggest question however was turning
around Ranbaxy which had already been under financial stress for several quarters. Its four plants had been barred from
selling in the United States. It has already admitted that it had falsified data while seeking approval of the United States Food
& Drug Administration, for its generic medicines and also paid a penalty of $500 million to settle the matter (Dey, Sun
Pharma draws up plan to fix ailing Ranbaxy, 2014).
3. Withdraw any applications found to contain untrue statements of material fact and/or a pattern or practice of data
irregularities that could affect approval of the application.
In addition, the consent decree prevented Ranbaxy from manufacturing drugs for introduction to the U.S. market and for
the President‘s Emergency Plan for AIDS Relief (PEPFAR) Program at the Paonta Sahib, Batamandi, Dewas, and
Gloversville facilities until drugs can be manufactured at such facilities in compliance with U.S. manufacturing quality
standards.
In 2013, Ranbaxy USA Inc., a subsidiary of Ranbaxy Laboratories Limited, pleaded guilty to three felony FDCA counts,
and four felony counts of knowingly making material false statements to the FDA regarding generic drugs made at two of
Ranbaxy‘s manufacturing facilities in India. It agreed to pay a criminal fine and forfeiture totaling $150 million and to settle
civil claims under the False Claims Act and related State laws for $350 million. This happened to be USA‘s largest financial
penalty paid by a generic pharmaceutical company for FDCA violations Specifically, Ranbaxy USA admitted to introducing
certain batches of adulterated drugs that included Sotret (branded generic form of isotretinoin, a drug used to treat severe
recalcitrant nodular acne), Gabapent in (used to treat epilepsy and nerve pain), and Ciprofloxacin (broad-spectrum antibiotic)
The FDA also followed up the above order with an import alert under which U.S. officials could detain at the U.S. border
drug products manufactured at Ranbaxy Laboratories, Ltd.‘s facility in Mohali, India. It‘s Mohali plant was prohibited from
manufacturing FDA regulated drugs until the firm‘s methods, facilities, and controls used to manufacture drugs at the Mohali
facility are established, operated, and administered in compliance with CGMP.
In 2014, the FDA prohibited the Toansa facility of Ranbaxy to manufacture and distribute active pharmaceutical
ingredients (APIs) for FDA-regulated drug products. Among others the FDA‘s form 483 listed numerous violations from
CGMP which included flies in the sample storage room, inadequate control over sample and non-adherence of procedures in
sample analysis. The report especially came strongly on the deliberate falsification of data by Ranbaxy through methods of
retesting suspect API results until acceptable results were obtained, or in failing that not reporting suspect results. Some other
lapses that were discovered during inspection included- samples not being analysed according to established laboratory test
method procedures, non-reporting of numerous test results, lack of written procedures and documentation of test results,
inadequate controls over computerized systems, backdating testing records and log books, and non-control of laboratory
samples to prevent mixing of samples. There were also inadequacies in laboratory facilities, maintenance of manufacturing
equipment, and calibration of analytical instruments.
4. Conclusion
The FDA lays down the toughest regulations in relation to drug discovery, manufacturing and distribution to ensure that the
American public gets access to quality drugs. Any manufacturer aiming to enter the U.S. market must comply with the
strictest standards of quality and safety. Given the huge anomalies that were discovered in Ranbaxy‘s manufacturing
facilities, it leads one to suggest that the same quality standards are not enforced by Indian drug regulators for drugs that are
manufactured, and sold to the Indian consumer. A very detailed investigative report on the regulatory and safety process of
the Indian drug industry has been compiled by Dinesh Thakur and Prashant Reddy T.(Thakur & Reddy, 2016) It outlines the
“fragmented federal drug regulatory framework, the weak investigation and enforcement mechanism under the Drugs and
Cosmetics Act, 1940, and the absence of fundamental quality testing and recall norms in Indian law” as responsible for the
extremely lax standards that prevent Indian consumers from consuming adulterated drugs. If in fact, the weakness of the drug
regulatory system did not exist, Ranbaxy Laboratories perhaps would never have been exposed to this kind of intense scrutiny
by the USFDA. This situation also does not portend well for Indian companies that would like explore international markets
especially the Western developed ones. If this situation is allowed to persist, quality and safety concerns will continue to
plague the reputation of Indian drug manufacturers. This will have long not only term public health implications but also
competitiveness concerns for Indian drug manufacturers both within and outside India.
by the company, until the USFDA pulled up Ohm also for GMP lapses in December 2009.
Bentley A. Hollander filed a case in a district court in Pennsylvania, complaining that Ranbaxy‘s US arm ―Ranbaxy
Laboratories Inc.‖ is marketing some products with false patent claims. The petitioner wanted Ranbaxy to be fined for falsely
marking articles with expired patents, as well as using these expired patents in advertising in connection with such articles,
all for the purpose of deceiving the public into believing that such articles are covered by these expired patents. The
March 2010
complaint rose from Ranbaxy‘s use of a patent (number 4,619,921) on the label of Ultra ate, a skin care brand, which the
company acquired from Bristol Myers Squibb along with 12 other dermatology products three years ago. The petitioner
argued that the patent rights over that product had expired about five years ago, much before the brand was acquired by
Ranbaxy and the company had no right to continue its mention on the product labels.
Ranbaxy Laboratories posted a consolidated net loss of Rs.2,982.70 crore in the fourth quarter ended December 31, 2011, on
February
account of provisions made in connection with the consent decree it signed with the U.S. authorities. The company had
2012
posted a net loss (after tax and minority interest) of Rs.97.40 crore in the same period previous year.
November It recalled some generic Lipitor, known as atorvastatin, in the United States after certain batches were found to contain glass
2012 particles.
The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border
September
drug products manufactured at Ranbaxy Laboratories, Ltd.‘s facility in Mohali, India. The firm will remain on the import
2013
alert until the company complies with
A cardiologist from Cleveland, Ohio questioned the effectiveness of drugs made by Ranbaxy to seven felonies in a case
December brought by the U.S Department of Justice by citing several cases of health issues faced by patients of his who used Ranbaxy
2013 drugs, He claimed that those whose symptoms were either worsening or not improving with these drugs saw significant
improvement after he switched them to drugs made by other manufacturers
The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing
January 2014
and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products.
Ranbaxy shares fell as much as 20 per cent on Friday after the US Food and Drug Administration banned products from the
company's Toansa plant in Punjab. The stock breached long-term support levels and most analysts turned bearish on Ranbaxy
January 2014 post the FDA move. The Toansa unit accounts for 70-75 per cent of APIs (active pharmaceutical ingredient) used in Ranbaxy
formulations and is the fourth Ranbaxy plant to be barred from making products for the US, which accounts for over 40 per
cent of the company's sales.
the system of quality control over drug production and promoting the rational use of drugs in the country
Creates an environment conducive to channelizing new investment into the pharmaceutical industry, to encouraging cost-effective
production with economic sizes and to introducing new technologies and new drugs,
Strengthens the indigenous capability for production of drugs.
Modifications In Drug Policy 1986
Modified in 1994 to make the domestic industry more internationally competitive.
The modifications were made on areas of licensing, basic stage production, review of items reserved for the public sector, foreign
investment, and foreign technology agreements.
Research and development was encouraged and pricing, span of control, ceiling prices, coordination between ministries etc.
Drugs (Prices Control) Policy 1995
Issued by the Government of India under Section 3 of the Essential Commodities Act, 1955 to regulate the prices of drugs.
Provides the list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by
Government and penalties for contravention of provisions among other things.
74 bulk drugs were put under price control and there was no price control on 70-75% of the retail pharmaceutical market.
Facilitates Win –Win situation for the government, but not for the industries.
Drugs (Prices Control) Policy 2013
Governed by national pharmaceutical pricing authority, based on national list of essential medicines.
Prices of 652 drugs are regulated by this act.
Ceiling and non-ceiling prices of drugs are specified.
Prices of the drugs are fixed by the mutual agreement of government and industries for the welfare of the public.
Pharmaceutical Policy 2002
Evolved to make the domestic industry more internationally competitive and directing it towards new initiatives.
Apart from the objectives of The Drug Policy 1986, its main objective was to encourage R&D in the pharmaceutical sector in a
manner compatible with the country‘s needs with particular focus on diseases endemic or relevant to India.
Aims at creating an incentive framework for the pharmaceutical industry which promotes new investment into the knowledge based
sector.
The Patents Act
The present Patents Act, 1970 came into force in the year 1972, amending and incorporating the existing laws relating to Patents and
Designs act 1911 in India.
The Patent (amendment) Act 2005 came into force from 1 st January 2005, which brought changes in the previous patent system of
India wherein product patent was extended to all subjects of technology consisting of food, drugs, chemicals and microorganis ms.
Section 3(d) introduced in to the said amendment act 2005 and introduces pharmaceutical product patents in India for the first time.
The Patent (amendment) Act 2005 defines what invention is and makes it clear that any existing knowledge or thing cannot be
patented.
National Pharmaceutical Pricing Policy 2012
It was notified on 07.12.2012.
Aims at bringing 652 commonly used drugs under the ambit of price control.
Seeks to limit itself to the central objective of promulgating the principles for pricing of Essential Drugs as laid down in the ―National
List of Essential Medicines – 2011.
The objective was to put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines –
―essential medicines‖ – at reasonable prices even while providing sufficient opportunity for innovation and competition to support the
growth of industry, thereby meeting the goals of employment and shared economic well-being for all.
Ranbaxy’s Vision and Mission Achieving customer satisfaction is fundamental to our business
• Provide products and services of the highest quality
• Practice dignity and equity in relationships and provide opportunities for our people to realise their full
potential
• Ensure profitable growth and enhance wealth of the shareholders
• Foster mutually beneficial relations with all our business partners
• Manage our operations with high concern for safety and environment
• Be a responsible corporate citizen
Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani
Schedule T
medicines.
Schedule Y The clinical trials legislative requirements are guided by specifications of Schedule Yof The D&C Act.
The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for
Medical Research (ICMR) has come out with draft guidelines for research in human subjects. These GCP
GCP guidelines
guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for good
clinical practice.
The Pharmacy Act,1948 The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India.
The Drugs and Magic
Remedies (Objectionable The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 provides to control the
Advertisement) Act, advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities.
1954
The Narcotic Drugs and
The Narcotic Drugs and Psychotropic Substances Act, 1985 is an act concerned with control and regulation
Psychotropic Substances
of operations relating to Narcotic Drugs and Psychotropic Substances.
Act, 1985
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