Editorial Notes

Editorial Notes 23rd November 2016

Coastal security; Why Navy and Coast Guard will not be enough? Generic vs Big Pharma; What is Data exclusivity? Data exclusivity norms in India; Arguments in favour of and against Data exclusivity.
By IT's Editorial Notes Team
November 23, 2016


GS (M) Paper-3: “Awareness in the fields of IT, Space, Computers, robotics, nano-technology, bio-technology and issues relating to intellectual property rights.”
GS (M) Paper-2: “Government policies and interventions for development in various sectors and issues arising out of their design and implementation.”


Generic vs Big Pharma reloaded



  • The Indian Pharmaceutical Alliance (IPA) took on the government, on what it considered to be a backdoor extension for data exclusivity norms in the country.
  • It pointed to the recent government proposal to change the four-year time limit for State-level drug regulatory approvals to 10 years, arguing that this effectively results in a long and damaging data exclusivity.

What is Data exclusivity?

  • Data exclusivity is a kind of intellectual property protection wherein clinical trial and other data submitted by an originator drug company cannot be used or relied upon by a drug regulatory authority to approve a generic version of that drug for a certain period of time.

Data exclusivity norms in India:

  • India has long resisted U.S. and EU pressure to institute data exclusivity norms, seeing it as a barrier to generic entry and more affordable drug prices.
  • Currently, as per the Drugs and Cosmetics Act (DCA)a drug manufacturer can go directly to a State regulatory authority and procure drug approval with data exclusivity for a period of 4 years.
  • It is this four-year period that is now sought to be enhanced to 10 years.

Arguments in favour of Data exclusivity:

  • Such protection gives the originator company the necessary commercial incentive to conduct expensive trials and take a potential drug to the market.

Arguments against Data exclusivity

  • If generic drug makers are forced to submit the same kind of clinical trial data that originators have submitted to the regulatory authority, then this does amount to data exclusivity.
  • Almost all generics will simply wait for the data exclusivity term (four years) to expire rather than undertake the expensive process of generating clinical trial data afresh, not to mention the sheer immorality of repeating animal studies and subjecting human volunteers to safety and efficacy tests in relation to the same drug molecule.

Process currently followed by Generic drug makers to avoid clinical trials:

  • Generic drugs are approved upon a simple showing of bio-equivalence: that the claimed molecule is the same as the one already approved.
  • And therefore, there is no sense in having the generic applicant repeat all clinical trials afresh.
  • However, bio-equivalence cannot be had easily, it has to be demonstrated through rigorous studies/data.

Current issues in approval norms:

  • The Drug and Cosmetics Act is not very clear on the kind of studies/data that a generic applicant is meant to submit.
  • Number of state regulators do not insist on bio-equivalence studies or any other studies for that matter prior to approving a drug for manufacture in that State.
  • Drug manufacturers opt to simply wait for four years and then approach State authorities rather than risking a more rigorous Central clearance.
  • Drug Controller General of India doesn’t even insist on separate local clinical trial data for new drugs. Rather they routinely dispense with the requirement of local clinical trials under a broad “public interest” exception.
[Ref: The Hindu]


GS (M) Paper-3: “Various Security forces and agencies and their mandate”
GS (M) Paper-3: “Challenges to internal”


Coastal security is the weak link in the nation’s security matrix



  • The anniversary of the AjmalKasab and other terrorists and the subsequent terror incidents is around the corner, coastal security management across the nine coastal states and four Union Territories has yet to fall in place.
  • Coastal security includes both military and police roles that make it a challenge for state governments to manage effectively.

Why Navy and Coast Guard will not be enough?

  • The Centre contributes considerably to coastal security in terms of marine platforms and funds.
  • The state governments would like to believe that the presence of the Indian Navy and Indian Coast Guard (ICG) across peninsular India is adequate to tackle sea-borne terrorist threats.
  • The Navy patrols the high seas beyond 200 nautical miles given the heavy tonnage of their warships.
  • The ICG covers the waters between 12 and 200 nautical miles.
  • In the process, the part of seas from the coastline to 12 nautical miles which is afloat with a high density of smaller craft like fishing boats, mechanised trawlers and dhows becomes the responsibility of the coastal/marine police forces.

Why police is not enough?

  • Today the police forces suffer from political interference and thereby lack professionalism,which reflects in terms of poor public security priorities.
  • The country has a poor policeman-to-population ratio with just one policeman for 761 people that translates into approximately 131 policemen per 100,000 population.
  • Ideally, a policeman should cater to just 568 people at the rate of 176 policemen per 100,000 population according to the Indian Bureau of Police Research and Development.
  • Therefore to expect the police forces to prioritise coastal security is unrealistic and it proves a weak link in the national security matrix.

Why a coastal police is necessary?

  • Only an active coastal police force could possibly perform such a role which involves random checks on cargo that these myriad boats carry.
  • Maharashtra chief minister suggested the proposal to raise a Central Marine Police Force (CMPF) in June at a meeting to review the status of India’s coastal security management in Mumbai.
  • The creation of a CMPF would relieve the police forces of an additional responsibility for coastal security.

How should the CMPF work?

  • The CMPF would have to be under the command of the ICG and mandated to patrol the coastal waters up to 12 nautical miles.
  • The police forces only require to designate an officer to coordinate with the ICG on operational matters.
  • The proposed CMPF could be staffed by former Navy officers to form the backbone of this force.
  • Also some members of the fishing community of each state could be recruited as marine police constables that would ensure local participation and overcome the language barriers and enhance familiarity with coastal waters.
  • State governments perceive coastal security as a subset of national security. Therefore, the constitution of a CMPF would prove necessary to secure the nation’s 7, 517-km coastline from sea-borne threats.

Case Study:

  • Among the nine coastal states, only Tamil Nadu has paid serious attention to coastal security due to the earlier threat from across the Palk Straits from the LTTE.
  • Raised in 1994, the Tamil Nadu Police Coastal Security Group (CSG) is a well-trained force tasked to protect the state’s 1,076-km coastline.
  • The marine/coastal security police forces in the other eight cannot be operationally compared with Tamil Nadu’s CSG.
[Ref: Hindustan Times]


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