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Anti-Monopoly and Competition Laws - Impact on the Indian Pharmaceutical

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Applied Clinical Research, Clinical Trials & Regulatory Affairs, 2015, 2, 153-157 153

Anti-Monopoly and Competition Laws - Impact on the Indian Pharmaceu-

tical Industry

Prerna Kaushik1, Swagat Tripathy2, Rishi Sharma3,* and Harish Dureja1

1
Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak-124001, India;
2
Cipla Limited, Jafarbhai Compound, L B S Marg, Vikhroli West, Mumbai, Maharashtra-400079, In-
dia; 3Department of Neurology, University of Missouri, Columbia, MO 65201-5297, USA

Abstract: Background: Competition is a process of economic race between market participants to draw
clients. The Indian competition law establishment is an early administration. Before the enactment of
the Competition Act in May 2002, Monopolistic and Restrictive Trade Practices (MRTP) Act was the
active law that managed certain parts of the opposition.
Objective: This manuscript highlights the purpose of competition laws for grappling with the monopo- Rishi Sharma
lies and restrictive trade practices with a particular focus on pharmaceuticals.
Conclusion: The Competition Act highlights the main features of new competition law which put back the old MRTP act
and also lets in the proscription of anti-competitive treaties, prevention of misuse of dominance and combinations which
prove detrimental to the competition in the market.

Keywords: Abuse of dominance, anti -competitive agreements, red -tapism, trade related intellectual property rights (TRIPS).

1. INTRODUCTION of vaccine should own WHO pre-qualification. It was to

eliminate some other manufacturers, dealers and traders of
Competition law and strategy are vital to overseeing
the vaccine and preferring the select ones. Competition law
medical services in numerous countries. In view of rivalry
in India has started to come to fruition as significant re-
law and strategy, address is on the issues concerning hostile
quirement activities obliging a crowd of commercial enter-
to aggressive works on winning in the pharmaceutical busi-
prises have advanced from initial complaint to a determina-
ness in India [1]. On the other hand, it is regularly noticed
tion of a violation and speak to the Supreme Court of India
that the obliged level of competition is frequently lost from
[3].
these business sectors. The pharmaceutical division is pro-
gressively under mounting, measure of investigation in de- The Indian Competition Act, 2002 was instituted to ele-
veloped nation jurisdictions viz., Europe and United States, vate and maintain a rivalry to secure the hobbies of shoppers
as evidences rivalry in pharmaceutical markets may not be and to guarantee flexibility of trade. The Competition Act
functioning admirably. For example, however, less new pre- reflects more settled rivalry law administrations which re-
scriptions are being conveyed to advertise, and the passage strict understandings between gatherings, mergers or blends
of generic medicines is now and again confined through an- and misuse of strength conduct that causes an apparent unfa-
ticompetitive practices. India being one of the greatest de- vourable impact on rivalry [4]. The aim of the current manu-
veloping markets of the pharmaceutical division, there has script is to furnish the basic variance between new and the
not been any far reaching study on the pharmaceutical busi- old and emphasize on the types of trade practices which is
ness from the point of view of rivalry law and arrangement prevalent in Indian market particularly focusing on pharma-
[2]. Accordingly, there are great motivations to investigate ceuticals.
the present condition of rivalry, winning in the pharmaceuti-
cal area in India. India’s competition policy was founded 2. HISTORY OF COMPETITIVE LAWS
along its past economic status which ensures that it should
not be concentrated in only a few hands for the common The economic policy of India was under the exacting
detriment or benefit. To give example in this context, for control of license system, also known as red-tapism. There
Bharat Biotech International Ltd- A.P. Health and Medical was a monopoly of government to permit the private players
Housing and Infrastructure Development Cooperation, the to manufacture goods. The amount of goods they give birth
High Court settled the case by appreciating government‘s to bring forth was not determined by the market demand, but
instruction in welcoming the tenders for the supply of Hepa- by the license regime and moreover, there was no substitu-
titis-B Vaccine only from the primary makers in India. And tion of Indian currency in the external universe [5].
the additional condition was that such crucial manufacturers
The economic policy took a great jump in 1969 in terms
of Monopolistic and Restrictive Trade Practices (MRTP) act.
*Address correspondence to this author at the Department of Neurology, The primary aims of the act were to thwart the concentration
University of Missouri, Columbia, MO 65201-5297, USA; of pecuniary power to the common hand and to regulate mono-
Mobile: 1-573-808-1603; Fax: (573) 884 4249;
E-mail: r_sharma88@Yahoo.com
polies in certain sector to prevent unfair trade practices [6].

2213-4778/15 $58.00+.00 © 2015 Bentham Science Publishers

154 Applied Clinical Research, Clinical Trials & Regulatory Affairs, 2015, Vol. 2, No. 3 Kaushik et al.

In 1991, the economy was liberalized by introducing remain balanced against the incentives and brand manufac-
Liberalization, Globalization and Privatization (LPG) policy. turers need to invest in producing ground-breaking new mer-
The opening of trade could be possible with the external uni- chandise. Case in point, less new medicines are being ap-
verse. The MRTP act had become out-dated in certain coun- proved on to advertise, and the passage of generic medicines
tries in the light of the global financial growth relating to is on instance restricted through anticompetitive practices.
competition laws. There felt a prerequisite to change the at-
Some incidence of such fight between the generic and
tention from cutting monopolies to encourage competition.
branded drugs is the lawsuit filed by the Swiss pharmaceuti-
Therefore, the modern competition law was developed. The
cal corporation - Novartis. Novartis desired an Indian patent
fundamental goal of competition law is to advance monetary
for its anti- cancer drug, Imatinib Mesylate, which has been
effectiveness utilizing rivalry as one of the methods for help-
patented as Gleevec in nearly 40 countries, including Russia,
ing the formation of business receptive to consumer feelings. China, Mexico, Germany, Taiwan, the UK, and in the USA.
The positives of flawless competition are manifold which
Nevertheless, the critics of Novartis’ action state that doing
allocates effectiveness and it guarantees the successful des-
so could ultimately undercut the making of generic drugs
ignation of assets & beneficial proficiency. And ultimately
that has given India a reputation as a hub for making afford-
it’s guaranteeing that expenses of creation to be reserved and
able medicine and could upshot in the losses of thousands of
as a building block productivity, which advocates an imagi-
persons who will no longer be able to meet the expense of
native practices [7]. the medications they entail [12].
2.1. Restrictive Trade Practices
2.3. Monopolistic Practices
A restrictive trade practice is one which has, or may
A monopolistic practice includes limiting or controlling
have, the effect of stopping, misleading or limiting competi-
production or distribution of properties, allowing quality of
tion in any style and in specific, which tends to block move-
goods or services to deteriorate and unreasonably increasing
ment of wealth or resources for production. The most usual
prices of goods or services. Monopoly can lead to absence of
case is linked in sales, which is a contractual arrangement
rivalry in the market, which give boost to high price of goods
between a consumer and producer where the consumer gets
with inferior character.
the desired object but after he agrees to buy another related
object from that producer [8]. The move is to anticipate
value cutting, which is liable to happen when there is an ab- 3. EMERGENCE OF COMPETITION LAW
sence of interest and organizations slice cost to get a cut of In that place should be a mind boggling question in one’s
the business. In a judgment, M/s Arora Medical Hall, Fero- brain that why the challenger should be necessary in market
zepur v. Physicists & Druggists Association, Ferozepur trade. It is because competition promotes efficiency, encour-
(CDAF), [9] the Competition Commission of India (CCI) ages innovation, which leads to higher productivity, facili-
forced a punishment of Rs 55.42 lakhs on Ferozepur Chem- tates better governance, promotes choice, improves quality,
ists and Druggists Association, which has been sentenced for ensures availability of commodities in abundance, improves
binding and controlling the procurement of medications and quality, facilitates economic growth, development and gen-
pharmaceuticals in Ferozepur [10]. eration of tax income. Therefore, with an objective of en-
Collusive tendering may take numerous shapes which in- hancing competition in the market competition act was
clude consent to submit indistinguishable offers, assertion passed in 2002 [13]. It was approved keeping in the location
with respect to present the most reduced offer, involuntary of the economic growth of the rural area to stop rehearses
inflated bids, i.e. "contract out" outside bidders etc. Such having a contrary effect on competition, to further and up-
courses of action may accommodate an arrangement of pay hold competition in markets, to defend the welfares of cus-
to unsuccessful bidders in view of a certain percent of profit tomers and to promise liberty of trade carried on by other
of effective bidders at the last phase of a certain period. partakers in the markets. The major divergences between the
These courses of action are planned especially to fortify the previous MRTP act, 1969 and competition act, 2002 are pre-
workplace of a certain part by others concurring not to fight sented in Table 1 [13, 14].
in his assigned business sector. A cartel will limit individu-
als' generation or deals when there is a surplus limit or where 3.1. Prevention of Anti-Competitive Arrangements (Sec-
the item is to raise costs [11]. tion 3)
No endeavor or relationship of the undertakings or per-
2.2. Unfair Trade Practices sons or relationship of persons should go into any plan which
Unfair trade practices include giving false and deluding is anticompetitive. It includes various agreements like cartel
explanations to the general population, offering of blessings, formation, bid rigging, collusive tendering etc. Thus, those
storing and pulverization of products, and so on. Unfair ex- agreements which are believed to cause an adverse effect on
change practices envelop a wide exhibit of torts, all of which competition is known as void agreements. Cartels involve
call for financial harm brought on by tricky or unlawful con- forming an arrangement between two or more enterprises for
duct. The lawful hypotheses that can be confirmed incorpo- their common benefits [15].
rate cases, for example, prized formula misappropriation,
unjustifiable rivalry, false promoting, palming off, weaken- 3.2. Prohibition of Misuse of Dominance Position (Section 4)
ing and criticism [3-5]. Competition amongst generic drugs Misuse of predominance emerges if a venture directly or
is a desirable objective as it typically brings substantial sav- by implication, forces unreasonable or biased (i) state of
ings to consumers. Even so, it is postulated that the same
procurement or offer of products or administration; or (ii)
Anti-Monopoly and Competition Laws Applied Clinical Research, Clinical Trials & Regulatory Affairs, 2015, Vol. 2, No. 3 155

Table 1. Differences in MRTP act 1969 and competition law 2002.

Competition Act 2002 MRTP Act 1969

Targets at encouraging rivalry Aims at restricting monopolies

Competition commission of India selected by the Indian Government MRTP Committee appointed by the collegiums.

Pursues to ban anti-competitive arrangements, misuse of central status and

Prohibit monopolistic, restrictive and unfair trade practices
to control amalgamations

Committee to exercise power in case of irrational restraints applied in rev-

No clear control with the MRTP in respect of IPRs
erence of Intellectual Property Rights (IPRs)

Based on principle of intellect Based on principle of natural justice

Unfair trade practices (UTP’s) not included UTPs covered in this deed

Penalty for crimes No penalty for offenses

Amenable Proactive and flexible

curement or offer of products or administration; or (ii) cost 5. KEY COMPETITION DISQUIETS

on buy or deal (counting predatory cost) of merchandise or
5.1. Anti-Competitive Rehearses Along the Pharmaceuti-
administration. cal Value Chain for Benefits and Extraordinary Ex-
change Recompenses
3.3. Combinations (Section 5)
Most of the pharmaceutical organizations overviewed
It includes the mergers and acquisitions. Mergers can
guaranteed mindfulness concerning the presence of tricky
share the assets of their partners in expanding their clientele practices in the pharmaceutical business. Some of these un-
in order to achieve market power and thus impact negatively scrupulous practices were related to unreasonable medica-
on competition. It leads to decrease in the amount of entities tions by specialists roused by payoffs got from pharmaceuti-
in the marketplace and increased share of the combined en- cal organizations. In some circumstances, the medication
tity. Recently, Sun Pharma took over the Ranbaxy by in- organizations, stockiest, retailers, and medical representa-
creasing its market share [15, 16]. In the pharmaceutical and tives, crookedly swell the expense of prescriptions and gen-
biotech commercial ventures, huge organizations regularly eral treatment [19].
have their judgments peeled for novel arrangements to indi-
cate to advance their organizations in a blasting medication 5.2. Misuse of Supremacy by Patent Dominations
business. The US pharma-Goliath Pfizer was sufficiently
India framed a procedure patent organization, which ana-
striking to bid AstraZeneca (AZ), a pharma colossal in Brit- lysts have conveyed supported the Indian therapeutic indus-
ain, an arrangement to gain the organization in lieu of £55 try flourish in a world class generics industry. In 2005, India
billion. The second illustration is the more positive merger changed its Patents Act, 1970 to come into full pleasantness
arrangement of the GSK-Novartis undertaking [17]. with its responsibilities under the concession to Trade-
Related Aspects of Intellectual Property Rights (TRIPS) as-
4. GOVERNING BODY sertion and transformed into a product patent organization.
When one patent is granted and it ultimately acts as protec-
Competition Commission of India (CCI) is a body corpo- tive cover, which in turn prevents others for anyone else to
rate having ceaseless progression, basic zeal and energy to copy it. When generic products become available, the market
secure, hold and discard property. The duties of the CCI competition often leads to substantially lower prices for both
[Section 18 of the Act] is to dispense with works on having the original brand name product and the generic forms. The
unfavorable impact on rivalry, progress and manage rivalry, major reason for the comparatively low price of generic
secure customers premiums and guarantee flexibility of ex- medicines is that competition increases among producers
change carried on by different members in business sectors which prevent any single company from dictating the overall
in India [16]. Its request is proportionate to declara- market price of the drug. With multiple firms producing the
tion/arrange by the High Court or Principal Civil Court and generic version of a drug, the profit-maximizing price gener-
claim against the determination of the Commission can be ally falls to the ongoing cost of producing the drug, which is
recorded to the Appellate Tribunal inside of 60 days from the usually much lower than the monopoly price. [12]
date of correspondence of the guideline, choice or request. A
further bid can be cleared against the parliamentary method 5.3. Backdoor Syndication Insurance and Exchange Legis-
lative Issues Influencing Competition from Generics Market
of the Appellate Tribunal, in the witness of the Supreme
Court inside of 60 days from the date of correspondence of In 2006, the USA set India on the distinct 301 urgency
the direction [18]. watch list for not imposing business model privileges for
156 Applied Clinical Research, Clinical Trials & Regulatory Affairs, 2015, Vol. 2, No. 3 Kaushik et al.

medical trial (information restrictiveness). It enquired the 6.3. Espousing other Measures to Encourage Generic
patent owner be given 5 years of selective business imposing Access by Lowering Market Obstacles
model rights. Pharmaceutical organizations, likewise pres- Bringing down geological hindrances and making utiliza-
surized India to do this. Information restrictiveness has tion of the regulation of universal depletion that India works,
turned into a subject in the Federal Trade Association (FTA) it is conceivable to import nonexclusive forms of low cost
with the European Union (EU) where EU is forcing India to medications [20].
contribute information for medical trial data put together by
a therapeutic organization [20]. This implies that paying lit- 6.4. Pharmaceutical Mergers and Acquisitions to be
tle heed to whether a patent is respected; a blended form of checked by the Competition Commission of India
that medication can't be enrolled amid that period. Subse-
quently, the effect of this on non-specific section into the Mergers and acquisitions in advancements markets, like
pharmaceuticals, represent a danger for stifling, so as to re-
business is huge. India should decisively oppose worldwide
sult section of items rivalry at the R & D and product devel-
weights to square section of generics and advance patent
opment stage. It is a worry that acquisitions that include
syndications of world-wide troupes [21].
takeover of bland organizations may prompt changes in the
5.4. Mounting Trends of Mergers and Takeovers in the needs of these organizations and unfavorably affect the op-
Pharmaceutical Sector position in generic markets [21].

Over the span of the last couple of years, the Indian 7. CONCLUSION
pharmaceuticals have witnessed a number of engagements
with multinationals wherein both parties get benefits by mu- With the passage of the new law, the competition regime
tual understanding. Bayer and Zydus Cadila assented to set in India has undergone a complete re-development. Though
up a joint effort known as Bayer Zydus Pharma (BZP), for it is unmanageable at this early stage to tell how effective or
the business and publicizing of pharmaceutical things in In- efficient the new legislation would be, it is for sure a sincere
dia. Other late joint endeavours fuse Sun Pharma working endeavor to satisfy the demands of the worldwide business
with Merck & Co. (MSD) to market and pass on Merck's community. CCI has been proactively carrying out the study
Januvia (sitagliptin) and Janumat (sitagliptin+ metformin) of competition advocacy since its constitution but now faces
under different brand names in India. In May 2011, Par a huge challenge and the chore in advance. It is desired that
Pharmaceutical Companies went into a legitimate agreement the CCI shall be capable to overcome any shortcomings in
to secure furtively hold Edict Pharmaceuticals, a Chennai- the act and iron out any difficulties in enforcement. Moreo-
based originator and producer of solid oral generics. Hikma ver, many developments in this area are anticipated by the
Pharmaceuticals pronounced in April 2011 that it had as- enactment of remedies.
sented to get a minority eagerness for Unimark Remedies, a
furtively held Indian creator of element pharmaceutical fix- CONFLICT OF INTEREST
ings and Active Pharmaceutical Ingredient mediators [22]. The views and opinions expressed in this manuscript are
those of the authors and not necessarily those of the institu-
6. REMEDIES TO THE PROBLEM tion at which the authors work. The authors assume full re-
6.1. Passable Norm of Section 3(d) and Postponement of sponsibility for this write-up and the accuracy of its contents.
Generic Medicines in the Therapeutic Sector
ACKNOWLEDGEMENTS
One of the key drivers of competition in the pharmaceu-
tical business, creating costs of medications to fall is the pas- Declared none.
sage of generics. One of the fundamental obstructions to
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Received: August 14, 2015 Revised: September 14, 2015 Accepted: September 19, 2015

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