Tag Archives: Dr. Reddy’s

The Power Of Color And Design In Pharma Branding

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On November 06, 2015, the District Court of Delaware of the United States (US) passed a temporary restraining order barring Dr. Reddy’s Laboratories (DRL) from selling in the US its generic version of AstraZeneca’s blockbuster anti-ulcerant drug Nexium, with immediate effect. 

This temporary order came in response to the petition moved by the drug innovator – AstraZeneca, objecting to the use of purple color in DRL’s generic equivalent of Nexium, launched in September 2015.

According to an estimate, this generic formulation could fetch a post tax profit of around US$25 to US$35 million to DRL in 2016. Nevertheless, the Delaware court order is pending a further hearing. The court has also asked both the companies to suggest the next course of action.

When color becomes an integral part of brand value creation: 

AstraZeneca’s effective branding of ‘purple color pills’ Nexium and Prilosec has helped the company to obtain this temporary restraining court order, which states: 

“As a result of such promotional efforts, there is undisputed evidence that the media and the public associate the color purple with AstraZeneca and its Prilosec and Nexium products.”      

The Court observed, though DRL product is not identical to AstraZeneca’s Nexium, still could confuse patients due to its association with the purple color.

In this context, it is worth noting, though a couple of other generic Nexium capsules are available in the US, none is purple in color. Teva’s capsules are green and blue and Mylan’s are white in color.

Can a right be established on branding ‘color’?

It appears so. In its Complaint to the Court against DRL, AstraZeneca (AZ) argued in favor of its successful branding of Nexium with ‘Purple Color, as follows:

  • AZ brand has offered relief to sufferers of severe heartburn and other disorders caused by stomach acid reflux through its “Purple Pills” Prilosec® and Nexium®, known as “The Purple Pill®.”
  • AZ has devoted significant resources over the years to advertise and promote its Prilosec® and Nexium® purple pills using the ‘look for’ purple advertising.                                                 
  • The preference for purple was purely for branding purposes—purple contributes nothing to the safety or efficacy of AZ’s products. 
  • AZ has continuously sold Nexium® from 2001 to present in purple colored capsules with either two or three gold-colored bands displayed on the purple capsules.
  • Thus, AZ’s Purple Pills have been famous for many years through extensive advertising both to doctors and patients and extensive publicity, among other reasons. 
  • If DRL is not enjoined from using the color purple, DRL’s purple generic pills are likely to cause confusion among consumers and others and are likely to dilute the distinctiveness of AZ’s federally registered purple color trademarks. 
  • DRL’s attempt to free-ride off the fame of AZ’s famous Purple Pills poses imminent irreparable harm to both AZ and the public if not enjoined.

I would like to remind the readers at this point that Pfizer also did branding of Viagra keeping the color of the pill as one of the key ingredients, as it is also well-known as the ‘Blue Pill’, across the world.

Does color of the pill matter to patients? 

In this regard, on July 15, 2014, an interesting study titled, “Burden of Changes in Pill Appearance for Patients Receiving Generic Cardiovascular Medications After Myocardial Infarction”, published in the journal of ‘Annals of Internal Medicine’, wanted to find out whether non persistent use of generic drugs among patients with cardiovascular disease after Myocardial Infarction (MI) is associated with the inconsistent appearance of their medications.

The study concluded, “Variation in the appearance of generic pills is associated with the nonpersistent use of these essential drugs after MI among patients with cardiovascular disease.”

Or in other words, the researchers found, 30 percent or more patients are likely to stop taking their medication because the unexpected change, can be confusing.

Impact of a branding strategy with color and design as integral parts: 

Even after a product goes off-patent, ‘Intellectual Property Rights (IPR)’ could still protect aspects of a pill design, which are not associated with product functioning.

The above study finds that in true sense, the shape and color of the tablets or capsules are very much intimately associated with the functional aspect of the product, as these characteristics established through effective branding exercise of the original product, help promoting patient compliance to various drugs, which is so important in combating serious ailments.

Effective branding with extrinsic factors: 

The above important research finding clearly establishes that even the extrinsic product features like, color and design, when used in an effective branding strategy, could have critical medical relevance for the patients.

Such clever pharma branding strategies are not just restricted to:

  • AstraZeneca’s “little purple pill” – Nexium
  • Or Pfizer’s “blue-diamond-shaped tablet” – Viagra.

There are many other examples of making extrinsic product features as effective branding tools. A few of these are as follows:

  • GlaxoSmithKline’s craftily designed a “tilt-tab” for its Parkinson’s disease brand Requip. This design makes it easier for the patients to pick up the tablets. Requip “tilt-tab” has been modeled with unconventional 5 sides and a pointed fulcrum that prevents it from lying flat.
  • Diovan blister packs of Novartis with calendar markings for pills, improved patient compliance significantly, as a research study established.
  • Special caps are now reportedly available that fit on most prescription drug bottles, containing a wireless chip that communicates with a light plug. The cap pulses orange light, when the patient forgets to take a pill.

An article published in the ‘Outsourcing-Pharma.com’ on March 11, 2014 states, Philadelphia based Colorcon, that works with many pharma manufacturers, both innovator and generic players, to shape and coat their tablets, has a library of 40,000 different colors and shapes of samples to choose from.

The color and design war in pharma branding has just begun: 

The importance of color and design as a pharma brand identity has started being realized today. The latest DRL case involving the color of AstraZeneca’s Nexium, close on the heels of similar other cases related to the blue color of Pfizer’s Viagra, has thrown open a critical question.

This query wants a specific answer, whether IP protection on Trademark would get extended to distinctive colors, which through branding initiatives have become strongly associated with a specific brand. Possibly the unprecedented lawsuit on the subject by AstraZeneca against DRL would ultimately settle the legal aspect of the issue, decisively.

Nevertheless, the importance of color and design as two key ingredients of successful pharma branding would remain unchallenged from ‘creative marketing’ stand point.

Conclusion:

There are market research studies that suggest that around 80 percent of visual information for any brand is related to color and design. Pharmaceuticals are no exceptions. Thus, these important extrinsic product features can be strategically leveraged with the intrinsic product benefits in a branding exercise, to create a cutting edge value synergy.

In today’s environment of innovative branding strategy, the state of art tablet color and design technologies may be appropriately utilized by the pharma players to successfully build and also to get limited brand protection, as happened in the case of Nexium of AstraZeneca.

The research findings, as mentioned above, that such type of branding has important medical relevance too, may be construed as an additional silver lining to this exciting process.

In my view, the aforesaid strategy would make enormous sense for branded generic drugs too, though with tailor-made approaches, which could well be a different discussion altogether.

Keeping all this in perspective, I reckon, innovative use of the power of color and design in pharma ‘branding’ exercise, including a comprehensive communication strategy with appropriate platforms, could provide an important leading edge for significant commercial success of a brand.

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Just Born A Pharma Goliath: Would India Be Impacted?

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Just born a potential pharma Goliath, as Actavis – the Dublin-based one of the largest global generic drug makers, in its biggest ever purchase, acquires New York based R&D based pharma major – Forest Laboratories, for a whopping US$ 25 billion.

It is worth noting that as on date Actavis has grown mainly through Mergers and Acquisition (M&A) route. In 2012, the company took over American generic drug major Watson Pharma for €4.5 bn and then Ireland’s Warner Chilcott, marketing patented drugs for gastrointestinal and urological conditions, for US $8.5 bn. Post buy out of Forest Laboratories, Actavis would have annual sales turnover of US$15 bn.

So far, mostly R&D based Pharma players acquired generic drug makers:

This acquisition is interesting. The reason being, since the last few years, mostly research based global pharmaceutical companies are taking over generic pharma players in the emerging markets with a reasonable speed. To cite a few examples:

In June, 2010, British drug major GlaxoSmithKline (GSK) announced acquisition of ‘Phoenix’, a leading Argentine pharmaceutical company focused on the development, manufacturing and marketing of branded generic products, for a cash consideration of around US $253 million. With this acquisition, GSK planned to accelerate its business growth in Argentina and the Latin American region.

Similarly, Paris based Sanofi with the acquisition of Zentiva, became an important player in the European generic drug market. Zentiva, is also a leading generic player in the Czech, Turkish, Romanian, Polish, Slovak and Russian markets, besides the Central and Eastern European region. In addition to Zentiva, in the same year 2009, Sanofi also acquired other two important generic players, Medley in Brazil and Kendrick in Mexico.

In February 2014, the German Drug major Bayer reportedly announced that it would buy Dihon Pharmaceutical Group Co of China, expanding the German company’s footprint in a key growth country. Dihon’s products are also sold in Nigeria, Vietnam, Myanmar and Cambodia. Privately held Dihon specializes in ‘Over-The-Counter (OTC)’ and herbal ‘Traditional Chinese Medicine (TCM)’ products.

Back home, MNCs acquired the following generic companies from 2006 to 2011:

Year Indian Companies Multinational Companies

Value ($Mn)

 Type of Deal
2006 Matrix Labs Mylan 736 Acquisition
2008 Ranbaxy Labs Daiichi Sankyo 4,600 Acquisition
Dabur Pharma Fresenius Kabi 219 Acquisition
2009 Shantha Biotech Sanofi-aventis 783 Acquisition
2010 Orchid Chemicals Hospira 400 Acquisition
Piramal Healthcare Abbott 3,720 Acquisition
Paras Pharma Reckitt Benckiser 726 Acquisition
2011 Universal Medicare Sanofi 110 Acquisition
2013 Mylan Agila Specialities 1750 Acquisition

Key drivers for generic acquisition:

From 2012 to 2015 patented drugs with a combined turnover of US$ 183 billion have already faced or would face intense generic competition resulting in, as high as, around 90 percent price erosion for those products. It is not just patent expirations that are exerting pressure on innovator companies. Added to this, a relatively weak R&D pipeline and increasing focus of various governments to reduce healthcare costs, have forced many research based global pharma players to imbibe the inorganic growth strategy in the generic space to quickly grab a sizable share of this large and fast growing market, especially in the emerging economies of the world.

Actavis acquisition is different:

In the above light Actavis’s acquisition of Forest Laboratories is quite different. Here, instead of a predominantly research-based company’s acquiring a generic player, a basically generic drug major has bought a research based global pharmaceutical player.

Interestingly, Forest Laboratories follows a unique R&D model. It is focused on, instead of discovering on its own, identifying strong medically relevant product candidates and guiding them through the complex development lifecycle, from proof-of-concept through post-marketing.

Strong global portfolio of both generic and patented drugs:

Post buy out, Actavis would have a strong combo-portfolio of generic drugs together with a relatively robust line-up of a diverse range of patented products, spanning across therapy areas such as Anti-Infective, Respiratory, Cardiovascular, Central Nervous System, Gastrointestinal, Obstetrics and Pain Management and that too not just in the emerging markets, but globally, unlike many others.

In addition, acquisition of Forest Laboratories would also provide Actavis access to former’s large US sales teams, transforming the merged entity a formidable force to reckon with in the topmost pharmaceutical market of the world, besides many others.

An intriguing recent decision:

That said, it is interesting to note that in January 2014, Actavis, then the second-biggest generic drug maker by market capitalization, announced that it would quit China as “It is not a business friendly environment… China is just too risky”. This is indeed intriguing, because by 2015, China’s generic market is expected to be close to US$ 82 billion.

Be that as it may, post acquisition Actavis would be in a position to offer all its customers in all the markets of the world a rainbow of products from patented to generics, carving out a critical strategic advantage for itself in the global pharmaceutical market.

Impact in India:

The question now boils down to what would be the impact of the just born Goliath on the domestic pharmaceutical industry in India.

Differentiated generic business:

The generic drugs market is usually classified as simple generics, super-generics and biosimilars. To differentiate, by adding value in the generic medicines, many domestic players are gradually entering into the ‘Super Generic’ and ‘biosimilar’ category of drugs. For example, Dr Reddy’s Laboratories has reportedly chosen to go for a difficult to copy drug formulation with its blood-thinner Fondaparinux. Sun Pharma, on the other hand, is focusing on innovative delivery platforms for its ophthalmic drugs and oral contraceptives. Cadila is looking at newer drug delivery modes for its painkiller Diclofenac. So is Lupin in other areas. In the biosimilar arena, Biocon has already developed Trastuzumab formulation of Roche. Moreover, the biosimilar business of Dr Reddy’s Laboratories continues with its impressive growth trend, besides many other Indian players in the same fray.

Simultaneously, India is improving its effectiveness in ‘Contract Research and Manufacturing Services (CRAMS) space. As we have recently witnessed in India the alliances between Merck & Co and Cipla and earlier with Sun Pharma. Even prior to that, collaborative agreements of Pfizer with Aurobindo Pharma; GSK with Dr Reddy’s Laboratories; Abbott India with Cadila and many more, would vindicate this point.

Merck Serono of Germany also announced a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs) with Dr. Reddy’s Laboratories. The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions. Mylan has also signed similar agreement with Biocon.

Glenmark Pharma has chosen yet another route, by entering into collaboration with Forest Laboratories (now Actavis) in 2013, for the development of a novel mPGES-1 inhibitor for chronic inflammatory conditions, including pain management.

Advantage India, provided…

Global generic drugs market would get its next booster dose with reportedly around 46 drugs going off patent opening a market of another US$ 66 billion from monopolistic to intense generic competition in 2015.

Details of ANDA status from the US-FDA source, as I indicated in my earlier blog post, probably indicate that several Indian players have already started moving in that direction at a brisk pace, keeping their eyes well fixed on the crystal ball. Over 30 percent of Abbreviated New Drug Applications (ANDAs) and around half of the total Drug Master Filings (DMF) now come from the Indian Companies. In 2013 alone, the US-FDA granted 154 ANDAs and 38 tentative ANDAs to the Indian companies.

Despite all these, a serious apprehension does creep in, which finds its root in much-publicized fraudulent behavior of a few large Indian drug manufacturers, seriously compromising with the cGMP standards of some high profile global drug regulators. This challenge has to be overcome, sooner, to reap rich harvest out of the emerging global opportunities in the space of generic drugs.

Conclusion: 

Geographically, North America is the largest consumer of generic drugs followed by Europe and Japan. However, the highest growth of the generic drugs market is observed in the Asia-Pacific region. Besides Actavis, some of the major generic drugs manufacturers of the world are Mylan, Apotex, Hospira, Par Pharmaceutical., Sandoz International and Teva Pharmaceutical.

From India, Ranbaxy Laboratories (before the recent fiasco), Dr. Reddy’s Laboratories, Lupin and Sun Pharma, besides many others, are competing quite well in the global generic drugs market with success.

Though Actavis has its manufacturing operations in India with its registered office located in Mumbai, the company is not yet engaged in serious local marketing operations in the country. In 2006 as Watson Pharma Pvt Ltd., the company acquired Sekhsaria Chemicals in a move to push forward its generic drug agenda globally. In 2005, it acquired a manufacturing facility in Goa from Dr. Reddy’s Laboratories to produce solid dosage generic drugs for the US market.

Taking all these into considerations, if much deliberated cGMP issues with the foreign drug regulators are resolved sooner, Actavis is not expected to make any major difference for Indian pharma players either in the domestic market or for that matter globally, any time soon.

Thus Indian pharma players are unlikely to be adversely impacted with the emergence of this new potential Goliath in the global pharmaceutical landscape.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Is Fraud or Negligence in Drug Quality Standards Not a Fraud on Patients?

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As we know, a substance is called a drug when it has scientifically proven and well documented efficacy and safety profile to reduce both mortality and morbidity of patients. Any fraud or negligence in the drug quality standards, for whatever may be the reasons or wherever these take place, is a fraud on patients and should warrant zero tolerance.

A perception survey on drug quality:

According to a poll released in 2010 by the ‘Pew Charitable Trusts’s Prescription Project’ of the United States:

  • More than three out of four voters are confident that prescription drugs made in the USA are free from contamination
  • While less than one in 10 feel confident about medications made in India or China.
  • 54 percent of Americans distrusted Indian drugs and 70 percent distrusted Chinese drugs.
  • “When you buy a shirt, it will say right on the label where it was made, but when you get a pharmaceutical, you don’t know.”

Despite all these, the survey points out that in 2007, 68 percent of the ingredients of all drugs sold worldwide came from India or China, as compared to 49 percent in 2004.

Experts comment that USFDA does not have either people or resources required to monitor manufacturing in the geographically widespread locations, as these are today.

Recent spate of charges against Indian pharmaceutical companies – a vindication?

Recent spate of charges against some top ranked Indian companies, will further dent the image of India not just in the United States or Europe, but also as a pharmacy of high quality yet low cost generic drugs for the developing countries of the world.

In May 2013, well known India-based pharma major Ranbaxy reported to have pleaded guilty to criminal charges of manufacturing and distributing some adulterated medicines, produced at its Paonta Sahib and Dewas, facilities and agreed to US$ 500-millon settlement. Can this be considered as a vindication of the above perception on the quality of ‘made in India’ drugs?

The view of WHO:

Interestingly the World Health Organisation (WHO) even after the above USFDA indictment has commented that at present it has no evidence that Ranbaxy manufactured medicines that are currently prequalified by WHO are of unacceptable quality.

Indian drug regulator initiates action:

It is good to know that the Drugs Controller General of India (DCGI) and the Ministry of Health will reportedly decide the way forward in this matter on completion of a fact-finding study initiated by the Central Drugs Standards Control Organization (CDSCO) on the subject.

Other incidents in India:

Following are examples of other reported serious regulatory violations involving the domestic pharmaceutical companies:

No.

Year

Company

Issue

Status
2009 Lupin USFDA warning for Mandideep plant Resolved in 2010
2010 Claris Life Sciences USFDA ban products for manufacturing norms violations Ban revoked in 2012
2011 Zydus Cadila USFDA warns Co. over Moraiya, Gujarat Facility Ban revoked in 2012
2011 Dr Reddy’s USFDA bans sale of drugs from Mexico facility Ban revoked in 2012
2013 Jubilant Life Sciences Gets USFDA warning for Canada facility Company taking corrective steps
2013 Wockhardt Banned from exporting products from its Aurangabad factory to the US due to quality concerns In discussion

Source: The Economic Times (May 22, 2013), Financial Express (May 25, 2013)

Though some other countries also have faced bans from exporting products, it cannot be taken, I reckon, as any consolation by anyone.

A Mumbai Hospital demonstrated the mood of zero tolerance:

The above expression of good intent should not just remain as a ‘lip service’. Indian drug regulator is expected to take a leaf out of all these allegations and initiate appropriate audit as required. Otherwise, exhibiting zero tolerance, like Jaslok Hospital of Mumbai, many other institutions will ask their doctors not to prescribe products of these companies to protect patients’ interest. More hospitals reportedly are mulling similar action against Ranbaxy.

IMA expresses apprehension:

Even ‘The Indian Medical Association (IMA)’ has reportedly asked the DCGI to investigate quality of medicines manufactured by Ranbaxy.

It happens in the ‘heartland’ too just as in the ‘hinterland’:

Contrary to the above poll released in 2010 by the ‘Pew Charitable Trusts’s Prescription Project’, pointing accusing fingers, in this respect, exclusively to India and China, may not be just fair. Incidents of such regulatory violations are not just restricted to Indian pharmaceutical companies either. Unfortunately, these happen with the global majors too.

None of these should be condoned in any way by anyone and attract as much global publicity, public wrath and zero tolerance, as all these would possibly deserve.

Following are some examples:

No

Company

Issues with USFDA

Consent decree signed (year)

Issue status

Penalty amount
Schering-Plough GMP violations affecting four manufacturing sites and 125 products

Yes (2002)

Closed (2007)

 $500 Mn.
GlaxoSmithKline Manufacturing deficiencies found at Puerto Rico facility

Yes (2005)

Pending

 $650 Mn. Bond
Wyeth GMP violations at plant in Pennsylvania and New York which were producing FluShield

Yes (2000)

Pending

 $297 Mn. Plus 18.5% of sales of FluShield
Abbott Labs Non-conformance with quality system regulations for in vitro diagnostic products at an Illinois facility

Yes (1999)

Pending

 $212 Mn.
Boehringer Ingelheim To bring its Ohio facility into compliance with regulatory requirements

Yes (2013)

Pending

 Not specified

Source: Financial Express (May 25, 2013)

Further, in December 1998 the US FDA reportedly had stopped shipments of Abbott Laboratories’ clot-busting drug Abbokinase till the company had resolved undisclosed manufacturing problems at its plant. Abbott subsequently resolved this to the satisfaction of the drug regulator.

Even end May 2011, the USFDA reportedly raised concerns about contamination of drugs of the American pharmaceutical major – Hospira, at its Indian manufacturing facility.This issue was highlighted as the latest in a string of manufacturing and quality problems dogging the company since 2010.

American lawmakers demand thorough review of USFDA oversight procedures:

Pressure has reportedly started mounting in the United States for a thorough review into the effectiveness of oversight procedures for all bulk drugs and formulations manufactured in foreign facilities.

Simultaneously, there is also a specific demand for an in-depth review of all actions of the US regulator for so many years, which allowed Ranbaxy’s ‘massive fraud to remain unchecked’.

Beyond regulatory oversight, need robust internal system driven model as a fire-wall:

To address such issues only drug regulators interventions may not be just enough, maintaining total integrity of ‘Supply Chain’ of an organization proactively in a well structured, fool-proof and a system-driven way, will continue to play the most critical role. This will help creating ‘fire-wall’, which will be difficult to breach.

The scope of Supply Chain:

The scope of ‘Supply Chain’, which is comprised of the entire network of entities from vendors who supply raw and packaging materials, manufacturers who convert these materials into medicines, together with warehouses, distributors, retailers and healthcare centers who will reach these medicines ultimately to patients exactly the way these will deserve.

Thus, just not in the manufacturing process, any breach of security at any place of the supply chain can cause serious problems to patients. 

Accordingly, pharmaceutical companies need to adequately invest along with appropriate staff training programs to ensure that the Supply Chain Integrity is maintained, always.

Supply Chain Security (SCS) is critical:

SCS, therefore, deserves to be of prime importance for the pharmaceutical companies across the globe. Recent high profile SCS related cases, as mentioned above, have exposed the vulnerability in addressing this global menace effectively.

All pharmaceutical players should realize that not just ‘show-off’, an effective integrated approach is of paramount importance to eliminate this crime syndicate, which is taking lives of millions of patients the world over.

Mixing-up counterfeit drugs with this menace may not be prudent:

Shouting for counterfeit drugs involving mainly intellectual property related issues, may be  important, but will in no way help resolving self-created menaces arising out of breach of supply chain integrity endangering million of lives, in another way.

Though an expensive process, can’t be compromised:

It is worth repeating, securing pharmaceutical supply chain on a continuous basis is of critical importance for all the pharmaceutical players across the globe. However, the process will no doubt be expensive for any company.

Like other industries, in the pharmaceutical sector, as well, cost effective procurement is critical, which entices many pharmaceutical players, especially, in the generic industry not to go for such expensive process just to maintain the SCS.

A serious SCS related tragedy:

I would like to reinforce my argument on the importance of SCS with the following example of the ‘Heparin tragedy’ where the supply chain integrity was seriously violated with ‘ingeneuity’.

In the beginning of 2008, there were media reports on serious adverse drug events, some even fatal, with Heparin, a highly sulfated glycosaminoglycan of Baxter International. Heparin is widely used as an injectable anticoagulant. Baxter voluntarily recalled almost all their Heparin products in the U.S. Around 80 people died from contaminated Heparin products in the U.S. The US FDA reported that such contaminated Heparin was detected from at least 12 other countries.

A joint investigation conducted by Baxter and the US FDA ascertained that the Heparin used in batches associated with the serious adverse drug events was contaminated with Over Sulfated Chondroitin Sulfate (OSCS). It was reported that Heparin Scientific Protein Laboratories, Changzhou, China supplied Heparin to Baxter.

The cost of OSCS is just a fraction of the ingredient used in Heparin. Being driven by the criminal profiteering motive the manufacturers in Changzhou, China had reportedly used OSCS for highly sulfated glycosaminoglycan, as the former could not be detected by the pharmacopeia test in use, until 2008. This is because OSCS mimics Heparin in the pharmacopeia test. Post this criminal event, at present, all over the world more specific pharmacopeia test methods have been adopted for Heparin.

Stakeholders need to be extremely vigilant:

Considering all these, pharmaceutical players and the drug regulators from across the world should put proper ‘fool proof’ systems in place to eliminate the growing menace of criminal adulteration of APIs, drug intermediates, excipients entering in the supply chain together with preventing any breach in their logistics support systems.

Apprehension against generic drugs as a class:

Taking advantage of the situation, one can possibly say, as some vested interests have already started propagating that generic equivalents of the branded drugs are really not quite the same in quality.

However, the point that cannot be ignored is the comment of a senior USFDA, who was quoted in the same article saying, “I have heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards.“

Generic drug manufacturers should make serious note of such comments and act accordingly to allay prevailing lurking fear on the use of generic medicines, in general, though small in number.

Conclusion:

Following the recent series of incidents including that of Ranbaxy, the image of India as a low cost generic drugs manufacturer of high quality could get adversely impacted. Although there are enough instances that such things happen in the developed world, as well, including the United States.

Moreover, in the backdrop of high decibel quality concerns raised by USFDA, the level of apprehension regarding effectiveness of generic drugs made in India may increase significantly, unless some tangible, well thought out and highly publicized remedial measures are taken forthwith.

The decision of Jaslok Hospital, Mumbai advising their doctors for not using Ranbaxy products to patients on the same ground, will further strengthen the public apprehension.

Whatever may be the reason, as long as any company is in the business of manufacturing medicines, there should be demonstrable zero tolerance on any compromise, fraud or negligence in the drug quality standards. Any fraud and negligence in drug quality, I reckon, is virtually a fraud against humanity.

That said, changing mindset towards a strong corporate governance by walking the talk, all pharmaceutical companies must guarantee safe and high quality medicines to the society, come what may.

This, I believe, could be achieved by putting in place a robust SCS system and ensuring that this is not compromised in any way… anywhere…ever… for patients’ sake…both globally and locally.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.