Guidelines-for-Evaluation-of-Nanopharmaceuticals-iastoppers
PIB Daily

PIB Daily – 25th October 2019 – IASToppers

Guidelines for Evaluation of Nanopharmaceuticals; Vigilance Awareness Week; Central Vigilance Commission (CVC); Open General Export Licences (OGELs);
By IASToppers
October 25, 2019

Contents

Polity & Governance

  • Vigilance Awareness Week to be observed from 28th October to 2nd November

Issues related to Health & Education

  • Guidelines Released for Evaluation of Nanopharmaceuticals in India

Key Facts for Prelims

  • Raksha Mantri approves issuance of two OGELs for export of certain parts and components

 

[Note: Today’s PIB Daily News are already covered in Today’s Current Affairs Analysis. This PIB News Analysis news are only for those who wants to get only PIB news]

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Polity & Governance

Vigilance Awareness Week to be observed from 28th October to 2nd November

The Central Vigilance Commission (CVC) observes the Vigilance Awareness Week from 28th October to 2nd November, 2019.

Vigilance-Awareness-Week

ABOUT VIGILANCE AWARENESS WEEK

Vigilance-Awareness-Week-1

  • Vigilance Awareness Week is observed every year during the week in which the birthday of Sardar Vallabhbhai Patel (31st October) falls.
  • The theme for Vigilance Awareness Week 2019 is ‘Integrity- A way of life’.

Key Activities:

  • The establishment of ‘Integrity Clubs’ in schools and colleges to cultivate ethical values in the leaders of tomorrow.
  • Awareness Gram Sabhas’ are organized for dissemination of awareness in Gram Panchayats (in rural and semi-urban areas) to sensitize the rural citizens about the ill-effects of corruption.

ABOUT CENTRAL VIGILANCE COMMISSION (CVC)

Central-Vigilance-Commission

  • The Central Vigilance Commission (CVC) is the main agency for preventing corruption in the Central government.
  • It was established in 1964 by an executive resolution of the Central government, on the recommendations of Santhanam Committee on Prevention of Corruption(1962–64).
  • The CVC was neither a constitutional body nor a statutory body. Later, in 2003, the Parliament enacted a law conferring statutory statuson the CVC.
  • In 2004, the CVC has been designated as the agency to receive and act on complaints or disclosure on any allegation of corruption or misuse of office from whistle blowers under the “Public Interest Disclosure and Protection of Informers’ Resolution” (PIDPI), which is popularly known as “Whistle Blowers” Resolution.
  • It has all the powers of a Civil courtwhile conducting any inquiry.
  • The Commission is also empowered as the only designated agency to take action against complainants making motivated or vexatious complaints.
  • The CVC is conceived to be the apex vigilance institution.

Members

  • The CVC consists of a Central Vigilance Commissioner (chairperson) and not more than two vigilance commissionersappointed by the presidenton the recommendation of a three-member committee consisting of the prime minister as its head, the Union minister of home affairs and the Leader of the Opposition in the Lok Sabha.
  • They hold office for a term of four years or until they attain the age of 65 years, whichever is earlier. After their tenure, they are not eligible for further employment.

Role and Functions

  • Exercise superintendence over the functioning of the Delhi Special Police Establishment(DSPE) insofar as it relates to the investigation of offences under the Prevention of Corruption Act, 1988; or an offence under the Cr.PC for certain categories of public servants.
  • To inquire or cause an inquiry or investigation to be made into any complaint received against any official belonging to such category of officials specified in CVC Act, 2003.
  • Tender advice to the Central Governmentand its organizations on such matters as may be referred to it by them.
  • Exercise superintendence over the vigilance administrationsof the various Central Government Ministries, Departments and Organizations of the Central Government.
[Ref: PIB]

 

Issues related to Health & Education

Guidelines Released for Evaluation of Nanopharmaceuticals in India

The Union Minister for Science & Technology, Earth Sciences and Health & Family Welfare released Guidelines for Evaluation of Nanopharmaceuticals in India.

Evaluation-of-Nanopharmaceuticals-in-India

ABOUT THE GUIDELINES FOR EVALUATION OF NANOPHARMACEUTICALS

  • The Guidelines are developed by Department of Biotechnology (Ministry of Science & Technology), Indian Council of Medical Research and Central Drugs Standard Control Organization.
  • The guidelines will apply to the nanopharmaceuticals in the form of finished formulation as well as Active Pharmaceutical Ingredient (API) of a new molecule or an already approved molecule with altered property.

SIGNIFICANCE

  • Facilitate research in line with the regulatory requirements.
  • Facilitate the decision making by regulator during clearances to newer products based on nanotechnology and similarly to researchers to get clearance for their products to launch in market.
  • Facilitate end users by the quality assured anticipated products in the market
  • Will give impetus to initiate activities for developing safety guidelines for other domains like agri-inputs and agri-products, cosmetics, implantable devices, through interventions of nanotechnology.
  • Will pave the way for significant benefits through such cutting edge technology and contribute to the mission on “Affordable Health Care for All”.

WHAT IS NANOPHARMACEUTICAL?

  • A nanopharmaceutical is defined as a pharmaceutical preparation containing nanomaterials intended for internal use or external application on human for the purpose of therapeutics, diagnostics and health benefits.
  • The nanomaterial is generally defined as material having particle size in the range of 1 to 100 However, if a material exhibits unique phenomenon which are attributable to its dimension beyond nanoscale range up to 1000 nm, the material should also be considered as nanomaterial.

nanopharmaceutical

NEED FOR NANOPHARMACEUTICALS

  • A long-standing issue in the drug industry is the difficulty of delivering the correct dose of vaccine/a particular active agent to a specific disease site. Since this is generally unachievable, active agents have to be administered in excessively high doses, thereby increasing the odds of toxic side effects.
  • Nanopharmaceuticals have enormous potential in addressing this failure of traditional therapeutics as they offer site-specific targeting of active agents.
  • Such precision targeting via nanopharmaceuticals will reduce toxic systemic side effects, resulting in better patient compliance.
  • Nanopharmaceuticals can also increase drug half-life by reducing immunogenicity and diminishing drug metabolism.
  • With these advantages, nanopharmaceuticals have the ability to extend the economic life of proprietary drugs, thereby creating additional revenue streams.
  • Also, Nanopharmaceuticals often offer an advantage of their reduced size.

 [Ref: PIB, Down To Earth]

 

Key Facts for Prelims

Raksha Mantri approves issuance of two OGELs for export of certain parts and components

Defence Minister has approved issuance of two Open General Export Licences (OGELs) for export of certain parts and components and intra-company transfer of technology to select countries.

Rajnath Singh approves issuance of two OGELs for export

  • The application processing and grant of OEGL will be taken care of by the Department of Defence Production.

ABOUT OPEN GENERAL EXPORT LICENCES (OGELS)

Open-General-Export-Licences

  • The open General Licence is a type of license that is used for the export license that is issued by the government for domestic suppliers.
  • It is a one-time export licence and will be granted to a company for a specific period (two years initially).
  • The items that are to be exported in India are categorised into three types. They are prohibited items, restricted items, and freely importable items.
  • The primary aim of the OEGL is to give a boost to the defence exports of India. This will also improve the ease of doing business and imports and exports.

Countries allowed for Export

  • The countries which are allowed under the OGELs are: USA, Canada, Belgium, France, UK, Spain, Germany, Sweden, South Africa, Japan, Mexico, and Poland.
  • There will be no exports to Special Economic Zones (SEZs).

ITEMS INCLUDED FOR EXPORT

  • The components of ammunition and fuse setting devices which will not include energetic and explosive materials.
  • Firing control and other related equipment for alerting and warning purposes.
  • Body protective items and related system.

ITEMS THAT ARE EXCLUDED FROM THE EXPORT

  • A complete aircraft or unmanned aerial vehicles (UAVs) are excluded. Any other components that are designed or modified in any way for UAVs are excluded under this license.
[Ref: PIB, Newsonair]

 

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