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In the past few weeks, India was witnessing a new form of censorship. The works of a fine arts student of Maharaja Sayajirao University of Vadodara were vandalized by communal activists on the ground that student has negatively portrayed the deities and there by hurt the religious sentiments of the

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

community. While the artists are making a hue and cry over the "trespass" over their creative domain, the so-called moral watch dogs are agitated about the "attack" on their personal beliefs. On which side, does the truth lie? Obviously, this standoff between creativity and intolerance is nothing

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

new to our country. Being a pluralistic society, we have always been open to diverse interpretations of art and culture and eloquently debated the metes and bounds of artistic freedom. However, the frequency and decibels of such dissenting voices has gone up in recent times and the way the protests

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

were carried out defies the democratic ethos and reasonable restraint expected from a secular pluralistic society. The erstwhile land of diversity, brotherhood and tolerance has suddenly become the abode of some temperamental touch-me-nots whose religious sensitivities are hurt at the drop of a ha

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

!

The Bizarre Paradox
India, as a melting pot of cultures is home to a vivid and versatile artistic tradition, which is subjected to all sorts of experimentations. Every artistic work bears the indelible imprimatur of the artist's passions, choices, predilections and prejudices, and i

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

is the manifestation of his/her wildest dreams and fantasies. We cannot expect them to be realistic and conforming all the time. If he/she is asked to get in to the straight jackets of contemporary morality, it is like asking a sculptor to chisel the statue to fit in to a particular mould, a shape

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

agreed to by every one. But then is the notion of contemporary morality reflects such unanimous choice or a collective conscience of the connoisseurs of art? How can it be for such a diverse and distinct society? Artists draw flak whenever they stray away from the trodden path and try to revisit t

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

e settled notions and beliefs. We cannot insist that an art form should neatly fit in to some pigeonholes of contemporary notions of religion and individual beliefs. The society should criticize, debate and discuss an artistic work and should very well decide to accept or reject it. But it should s

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

op there.

The Buck Stops Here

Once again, religious iconography has become a burning issue. When individual beliefs feels threatened by the divergent voices and need reassurances, it is setting a different precedent for India's age-old virtue of tolerance. It seems the pluralistic stat

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

e is on the verge of an identity crisis. However, this is not the dead end of tolerance in a democracy. We should clearly give space to divergent opinions as long as we have the freedom to accept or reject it. The constitution clearly stipulates how much noise we can make by defining the freedom of

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

expression and the reasonable restrictions. When voice of dissent relegates into irrational noises of intolerance with preachy overtones, the constitutional guarantees are jeopardized. Moreover, we have penal laws to check whether artistic freedom relegates to licentiousness. The law contemplates s

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ch transgression only when there is deliberate and malicious intention for out raging the religious feelings. In Vadodara, the exhibition was not meant for the public and it was more a part of internal assessment, conducted with in the precincts of the University. The activists have no locus standi

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

to question the internal matters of a University.

And finally, we should do a reality check as to how much these moral brigade were able to achieve. Remember the hullabaloo over the dress code imposed by Anna University, smoking in films has all failed to achieve the desired results. Even films w

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ich break away from stereo types are not spared. For instance, the film Nishabd which tells the story of a 60 year old man falls for his daughter's friend was accused of sending the wrong signals. Is the average Indian waiting to be strayed into prohibited territories at the drop of a hat? What do

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

e achieve by making there irrational noises? Of course, freedom of expression is an easy escape route to the artist. But it is a true test of tolerance to the society. Nevertheless, if we insist that artists should exercise restraint ignoring the compulsions of creativity, what would be the end pro

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

duct like? Living in a democratic secular society, the compulsions we face are quite different as the demarcations are too close and any mix up will trigger a controversy. For the same reason, what happened in Vadodara cannot be written off as one odd incident. Political forces are brewing a deadly

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

concoction by mixing religion and politics in poisonous proportions.

To determine what is objectionable and what is not by defining contemporary mortality is too dangerous a task to be left to the discretion of communal forces that holds a jaundiced view of religion. Culture offers a shared platfo

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

m where every one has their due. Obviously, this is the most prized feature of a democracy, that every one has an opinion. And it has the flip side too- that every one has got a veto power. True democracy lies in the reconciliation of these conflicting notions. And unfortunately, we have forgotten

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

the best means of squaring off the differences. Universities are laboratories of experimentation and academic discussions and debates as part of the curriculum should be left alone. Now the scenario is cluttered by too many voices, and it needs time for the heat and dust to set in. After all, why

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

o we need to join some opinionated bandwagons to determine the metes and bounds of artistic creativity? Much ado about nothing. Art transcends religion, culture and other human barriers. If one's belief is genuine and convictions are strong, it cannot be shaken by a different portrayal by an artist

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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