Is Sun Pharma Sailing In The Same Boat As Ranbaxy?

A ‘Warning Letter’ of May 7, 2014 from the USFDA to Sun Pharmaceuticals – the no.1 pharma major by market capitalization in India has nailed its Karkhadi, Vadodara, Gujarat based plant in India for similar data deletions as found at Ranbaxy.

Such data manipulation reportedly got Ranbaxy into so much trouble that it last year paid U$ 500 million and agreed to plead guilty to 7 felony charges.

The concerned Gujarat based plant of Sun pharma manufacturers the antibiotic cephalosporin.

This development came to the fore just weeks after Sun Pharmaceutical announced a US$ 3.2 billion deal to buy the much troubled, yet the largest generic drug company of India – Ranbaxy.

My earlier apprehensions on this deal:

At that time in my blog post of April 14, 2014, I expressed my apprehensions on this deal on four key areas, with as many words as follows:

1. Sun Pharma too is under USFDA radar:

As we know that along with Ranbaxy, Wockhardt and some others, Sun Pharma also had come under the USFDA radar for non-compliance of the Current Good Manufacturing Practices (cGMPs).

Under the prevailing circumstances, I apprehended, it would indeed be a major challenge for Sun Pharma to place its own house in order first and simultaneously address the similar issues to get USFDA ‘import bans’ lifted from four manufacturing plants of Ranbaxy in India that export formulations and API to the United States.

This could be quite a task indeed for Sun Pharma.

 2. Pending Supreme Court case on Ranbaxy:

Prompted by a series of ‘Import Bans’ from US-FDA on product quality grounds, the Supreme Court of India on March 15, 2014 reportedly issued notices to both the Central Government and Ranbaxy against a Public Interest Litigation (PIL) seeking not just cancellation of the manufacturing licenses of the company, but also a probe by the Central Bureau of Investigation (CBI) on the allegation of supplying adulterated drugs in the country.

Ranbaxy/ Sun pharma would, therefore, require convincing the top court of the country that it manufactures and sells quality medicines for the consumption of patients in India.

 3. CCI scrutiny of the deal:

Out of the Top 10 Therapy Areas, the merged company would hold the highest ranking in 4 segments namely, Cardiac, Neuro/CNS, Pain management and Gynec and no. 2 ranking in two other segments namely, Vitamins and Gastrointestinal.

Noting the above scenario and possibly many others, the Competition Commission of India (CCI), after intense scrutiny, would require taking a call whether this acquisition would adversely affect market competition in any of those areas. If so, CCI would suggest appropriate measures to be completed by the two concerned companies before the deal could take effect.

This would also be a task cut out for the CCI in this area.

 4. SEBI queries:

Securities and Exchange Board of India (SEBI), has already sought information from Sun Pharmaceutical on stock price movement and the deal structure.

According to reports, it is due to “Ranbaxy shares showing good movement on three occasions: first in December, then in January and subsequently in March 2014, just before the deal was announced.” This has already attracted SEBI’s attention and has prompted it to go into the details.

The matter is now subjudice.

The current scenario:

Out of my four identified areas of challenges, Sun Pharma has already started feeling the heat in the following two areas:

1. Quality issues with FDA:

The issue is extremely important, as to turn around Ranbaxy, this has to be addressed to the complete satisfaction of the USFDA. Otherwise, the game is a non-starter.

2. SEBI queries on stock price movement and the deal structure:

In this area, just today the Supreme Court reportedly refused to stay the Andhra Pradesh High Court order that stalled the US$ 4 billion Sun Pharma merger with Ranbaxy. Daiichi Sankyo and Ranbaxy had approached the Supreme Court seeking vacation of the stay of the status quo order by the High Court, which on April 25, 2014 directed the BSE and NSE not to approve the merger while admitting a petition by retail investors alleging insider trading in the US$ 4 billion deal.

The vacation bench comprising of Justices B S Chouhan and A K Sikri also directed the High Court to decide on Sun Pharma’s application seeking vacation of the status quo order within two days and posted the matter for further hearing on May 29. The judges observed that the Andhra High Court has no territorial jurisdiction over the merger process.

The outcome of this case would indeed be interesting and crucial for Sun Pharma.


Even if one keeps aside the three issues out of above four as the legal ones, the very first challenge related to USFDA on drug quality, would continue to remain as the ‘make or break’ area, for this deal to be commercially successful for Sun Pharma.

When USFDA reportedly nailed Sun Pharma’s Karkhadi , Vadodara, Gujarat based plant for similar data deletions as found at Ranbaxy, it may give a feeling that the acquirer Sun Pharma possibly is also sailing in the same boat as the acquiree Ranbaxy.

If this apprehension makes any sense, the moot question that comes up:

“Can one blind man show the right direction to another blind man sailing in the same boat in the midst of a storm?”

Let us wait for the eternal time to tell us the answer.

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 the revised Mashelkar Committee Report a ‘please all’ report, without taking any chance to ‘rock the boat’?

After repeated request and persuasion by the Government of India (GoI) in general and the Department of Industrial Policy and Promotion (DIPP) in particular ‘The Mashelkar Committee’re-submitted its reports to the GoI under the following terms of references:
Terms of Reference of the ‘The Technical Expert Group (TEG)’ Group:Following were the terms of references of the TEG:

1. Whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps.

2. Whether it would be TRIPS compatible to exclude micro-organisms from patenting.

Today I shall restrict my comments only on the point 1 of the terms of reference. Keeping this mind, let me try to analyze what various stakeholders had expected from the report. Against those expectations, what the report has actually articulated. And how have all these comments/ recommendations been able to keep almost all the stakeholders, with widely varying expectations, reasonably happy.

Why is the revised report a ‘please all’ report?

The key stakeholders who were interested in the revised report are as follows:

A. Research-based pharmaceutical companies who expressed concerns on the patentability of ‘incremental innovation’.

B. The Government of India (GoI) who may not be keen to revisit section 3(d) of the Indian Patents Act 2005, at least for now.

C. All voices supporting price regulations for patented products, in some form, the Department of Pharmaceuticals (DoP) being one of them.

D. Domestic generic pharmaceutical companies who want safeguards within Indian Patents Act 2005 against ‘ever greening’ of patents to ensure that there is no delay in launching generics after patent expiry.

Well crafted and well reasoned revised report from the TEG has been able to please all these stakeholders, to a great extent, which I shall analyze hereunder:

A. Expectations of the Research-based pharmaceutical companies from the report:

The research-based pharmaceutical companies seem to have expected that the report will recommend in specific terms that Section 3(d) of the Patents Act 2005 is not TRIPS compliant, as it restricts patentability of ‘incremental innovation’.

What the report actually says:

- “The Technical Expert Group (TEG) concludes that it would not be TRIPS compliant (Article 27 of TRIPS) to limit granting of patents for pharmaceutical substance to New Chemical Entities only, since it prima facie amounts to a statutory exclusion of a field of technology”.

- “The process of innovation is continuous and progressive leading to an ever extending chain of knowledge. Innovative incremental improvements based on existing knowledge and existing products is a ‘norm’ rather than an ‘exception’ in the process of innovation.”

“The TEG carefully examined the flexibilities allowed under the TRIPS Agreement to the member states (especially Articles 7 & 8 ) and also as a consequence of the Doha Declaration. The detailed analysis and reassessing provided in the report has led TEG to conclude that it is debatable as to whether national interest or the flexibility allowed under the agreement to member states would be accommodated by such ‘statutory exclusion’ of an entire class of (incremental)inventions.”

Very cleverly dodging the section 3(d) issue, the report supported the argument of the research-based pharmaceutical companies that ‘incremental innovation’ in pharmaceuticals cannot summarily be kept out of the criteria of patentability.

B. Government of India (GoI):

The GoI wanted to keep section 3(d) unchanged, till some sort of stakeholders’ consensus is arrived at in favor of its amendment, if at all.

What the report actually says:

“The TEG was not mandated to examine the TRIPS compatibility of Section 3(d ) of the Indian Patents Act or any other existing provision in the same Act. Therefore, the committee has not engaged itself with these issues.”

The TEG with this comment keeps the GoI satisfied, as the lawmakers are of the view that section 3(d) is not against incremental innovation. They believe, section 3(d) helps to avoid ‘frivolous’ innovation and ‘evergreening’ of patents by ensuring that all patentable ‘incremental innovations’ have ‘properties leading to incremental efficacy’. The revised TEG report, some people argue, vindicates this important point.

C. All voices supporting some form of price regulations of patented products, which include the DoP.

Both the DoP and other stakeholders want to keep the price of patented products under GoI control.

What the report actually says:

“Every effort must be made to provide drugs at affordable prices to the people of India”.

Thus the report satisfies the proponent of ‘affordable prices’ for patented products

D. Domestic generic pharmaceutical industry:

A large majority of the domestic generic pharmaceutical companies is of the opinion that most ‘incremental innovations’, are usually attempts to ‘evergreen’ patents for sustained commercially monopoly over the products for a much longer period of time than what it should have been otherwise. Hence patentability for ‘incremental innovation’ is to be restricted by law.

What the report says:

“TEG recommends that every effort must be made to prevent the practice of ‘ever greening’ often used by some of the pharma companies to unreasonably extend the life of the patent by making claims based sometimes on ‘trivial’ changes to the original patented product. The Indian patent office has the full authority under law and practice to determine what is patentable and what would constitute only a trivial change with no significant additional improvements or inventive steps involving benefits. Such authority should be used to prevent ‘evergreening’, rather than to introduce an arguable concept in the light of the foregoing discussion (paras 5.6 – 5.8 and paras 5.12 – 5.29) above of ‘statutory exclusion’ of incremental innovations from the scope of patentability.

Many will believe, with the above recommendations in their revised report, the TEG also meets the expectations of the domestic generic pharmaceutical industry, on this contentious issue.


The revised report of ‘The Mashelkar committee’ has definitely addressed its terms of references, pretty well. However, being ‘advisory’ in nature, the report was expected to be more specific, unambiguous and directional. Unfortunately, the comments/recommendations are neither specific without any ambiguity nor directional in nature; unless, between the lines the ‘please all’ report suggests its agreement with all stakeholders in unison, with perfect balance and elan, without making even a slightest attempt to ‘rock the boat’ in any manner, whatsoever.

By Tapan 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.