Drugs and Cosmetics Act, 1940

Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics act 2022 draft bill

Drugs and Cosmetics Act, 1940

• • Editorial discussion-
  • A new legislation that mirrors the old-
  • The new Drugs , Medical Devices and Cosmetic Bill is antiquated and needs to be revised. The Union government is set to replace the Drugs and Cosmetics Act, 1940, with legislation that also seeks to regulate medical devices, homeopathy and online pharmacies, apart from medicines and cosmetics.
  • Original act was enacted when the  Indian Pharmaceutical industry was in infancy.

• • At that time, the guideline theory of this law was based on manufactured grugs purchased by drug inspector from the open market.
  • If a drug failed quality testing ,the manufacturer could be jailed.
  • More rigorous system of regulation centered around the compliance of manufacturing units with good manufacturing practices(GMPs)

• • the one issue tha has come up in every review of the drug regulatory system since 1947 has been the uneven enforcement of the Drugs and Cosmetics Act across India.

• • This is because,  unlike the US which has a single federal agency   tasked with enforcing drig regulation across the country ,India has 37 agencies for the same job; one in each state and union territory  along with the Central Drugs Standard Control  organization (CDSCO) ,which is under the control of the Union Health Ministry.
  • State drug controllers are expected to license   drug   manufacturing and also conduct enforcement action such as sampling ,  testing and prosecution for substandard drugs.

• • The federation question-
  • The CDSCO’s role is limited to regulating imports and deciding whether new drugs  have adequate clinical evidence before  they can be sold.
  • Over the year,    even the CDSCO has started drawing samples for testing and  prosecuting   erring   manufacturers .
  • In addition the Health ministry is in charge of lying down rules and regulations and banning drugs which do not have supporting clinical evidences.

• • The bill proposes new definitions for clinical trials, over-the-counter drugs, manufacturers, cosmetics, medical devices, new drugs, bioavailability studies, bioequivalence studies, investigational new drugs, proprietary medicine and imported spurious drugs, among others.
    
    The bill introduces a separate definition for medical devices that includes all types of diagnostic equipment and its software. It will also include implants, devices for assistance with disabilities, a life support system, instruments used for disinfection, and any reagents or kits. The previous 1940 Act regulated medical devices on par with drugs.

• • TUNNEL VISION THAT IS ENDANGERING INDIA’S HISTORY—

• Section 20 of the Ancient Monuments and  Archaeological Sites and Remains (AMASR) Act of 1958, last amended  in 2010, prohibits construction  within a 100 metre radius of all Archaeological Survey of India (ASI)­protected monuments and regulates activities within another 300 metre radius. The new Bill proposes to revise this section. Hence  forth, expert committees will decide on the extent of the  prohibited and regulated areas around each monument and activities permitted   here  in.

• • The ASI protects around 3,700  archaeological sites and ancient  monuments. Taken together, they  mark milestones in India’s history .
  • The larger connections Historically, each monument was  integrally connected to the land-
  • scape around it. Here are a few examples.
  • Rock  cut sanctuaries from Barabar (Bihar) to Ajanta (Maharashtra) and from Masuru (Himachal Pradesh) to Guntu palli (Andhra Pradesh) were physically  connected to outcrops and canyons.
  • Pattadakal’s temples (Karnataka) were symbolically linked  to the Malaprabha river that  flowed past them.
  • Viramgam’s Munsar Talav (Gujarat) was the centre piece of a landscape consisting of interlocking ponds, sluice gates, decanting wells, irrigation  canals, and farmlands.
  • Lucknow’s Imambaras were tied to markets, palaces, processional roads, and gardens.

• • Endangering the commons

• • Rezoning land around ASI   protected monuments into industrial  ,commercial, or even residential  plots will thus deprive human and  animal communities of much  needed commons. Moreover, permitting construction work risks weakening the foundations of  centuries­   old edifices. The chances of  inadvertent damage are also high-
  • Now is the time to learn from  painstaking efforts to preserve our composite tangible heritage and the ecosystems that they are ensconced in. Conservation architect  Ritish  Nanda’s team at Humayun’s Tomb in Delhi has conserved a dazzling edifice and provided  meaningful employment to an entire basti.

• • In Bhubaneshwar, the Odisha government has formulated a  scheme to protect a cluster of ancient temples, tanks, and ponds to  nurture a sense of regional identity, restore habitats, and bring invisitor’s  in a methodical way.

• • Now is also the time to ask for  new, well  planned archaeological  excavations to be undertaken at  Sarnath and beyond, new partnerships to be formed with academic  institutions committed to the rigorous study of India’s past, and new  accessible articulations of why studying history is important today.

• • Such efforts — and not new laws  with more teeth, nor giant bronzes  of   menacing   lions   placed   atop  buildings — will safeguard and promote our heritage in the years to come.