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CDSCO Approvals

CDSCO Approvals

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 Get Your CDSCO Approved Drug Tested & Certified with EVTL India

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for drugs in India. CDSCO approval is required for all clinical trials conducted in India and for the import and manufacture of drugs in India. CDSCO approval is necessary to ensure that drugs are safe and effective and meet Indian regulatory standards.

As a business owner, you may be required to obtain approval from the Central Drugs Standard Control Organization (CDSCO) for certain activities related to drugs and pharmaceuticals.

For example, if you manufacture or import drugs or pharmaceuticals, you must obtain CDSCO approval. Similarly, if you are engaged in clinical research involving drugs or pharmaceuticals, you must obtain CDSCO approval.

The Central Drugs Standard Control Organization (CDSCO) is India's nodal regulatory body for pharmaceuticals and medical devices. CDSCO approvals are required to import and manufacture pharmaceuticals and medical devices in India.

  • CDSCO approvals can be requested by submitting an application form and the required documents to the CDSCO office.
  • The documents required vary depending on the type of product being imported or manufactured.
  • The CDSCO office will review the application and documents, and if everything is in order, will issue an approval.

It is important to note that CDSCO approvals are valid for a specific period and must be renewed before expiring. Manufacturers and importers should keep track of their CDSCO approvals and renew them promptly.

CDSCO approvals are required for all new drugs and medical devices before they can be marketed in India.

The documents required for CDSCO approval vary depending on the registered product type:

  • A clinical trial registration certificate and clinical trial protocol are required for new drugs, along with the results of pre-clinical and clinical studies.
  • For medical devices, a device registration certificate and technical file are required.

CDSCO approvals can be obtained through the online portal of the Ministry of Health and Family Welfare. The process is straightforward, and the approvals are typically granted within a few weeks.

Obtaining CDSCO approval is a complex process and can be time-consuming. However, it is essential to ensure that your business activities related to drugs and pharmaceuticals comply with the relevant regulations. Failure to obtain CDSCO approval can result in penalties, including fines and imprisonment.

EVTL India is a leading provider of CDSCO approvals in India. We help you get CDSCO approvals in no time so that you can start selling your products in the Indian market as soon as possible. We have a team of experienced professionals who know the ins and outs of the CDSCO approval process, and we will guide you through every step. We will also provide you with all the necessary documentation and support needed to get your products approved by the CDSCO.

PRODUCTS UNDER BIS REGISTRATION SCHEME

As of now, There are following products which needs be registered with BIS and require BIS Registration to Manufacture/Import and sell the product in the INDIAN market. Click on below listed products for more information. Call us at +91-9560 935 898/+011-49872660 Contact or Email at contact@evtlindia.in for more details.

BIS Products

Oil Well Cement - IS 8229

Masonry Cement - IS 3466

Super Sulphated Cement - IS 6909

Portland Slag Cement - IS 455

Sulphate Resisting Portland Cement - IS 12330

High Alumina Cement for Structural Use - IS 6452

Rapid Hardening Portland Cement - IS 8041

Portland Pozzolana Cement-Part1 Fly-ash based - IS 1489 (Part-1)

Composite Cement-Specification - IS 16415

Ordinary Portland Cement - IS 269

Portland Pozzolana Cement-Part 2 Calcined clay based - IS 1489 (Part -2)

Low Heat Portland Cement - IS 12600

High Alumina Refractory Cement - IS 15895

Microfine Ordinary Portland Cement-Specification - IS 16993

White Portland Cement - IS 8042

Hydrophobic Portland Cement - IS 8043

AC watt-hour meters, class 0.5, 1 and 2 - IS 13010

AC static watt-hour meters, class 1 and 2 - IS 13779

Safety of household and similar electrical appliances - Electric iron - IS 302 (Part-2/Sec-3)

Room Heaters-Safety of household and similar electrical appliances - IS 302 (Part-2/Sec-30)

Switches for domestic and similar purposes - IS 3854

Tungesten filament general service eletric lamps (upto 100 W) - IS 418

Elastomer Insulated Cables (Part-1) for working voltages up to and including 1100 V - IS 9968 (Part-1)

Electric stoves-Safety of household and similar electrical appliances - IS 302 (Part-2/Sec-202)

Residual current operated circuit breakers for household and similar uses-Part 1 Circuit breakers without integral overcurrent protection (RCCBs) - IS 12640 (Part-1)

Residual current operated circuit breakers for household and similar uses-Part 2 Circuit breakers with integral overcurrent protection(RCVOs) - IS 12640 (Part-2)

Electrical Accessories-Circuit breakers for overcurrent protection for household and similar installations - IS 8828

PVC insulated cables for working voltages upto and including 1100 V - IS 694

AC Static Transformer operated Watt-hour and VAR-hour meters, class 0.2S and 0.5S - IS 14697

Self Ballasted Lamps for General Lighting Services Part 1-Safety Requirements and Part 2-Performance Requirements - IS 15111 (Part-1 & 2)

Electric immersion water heaters-Safety of household and similar electrical appliances - IS 302 (Part-2/Sec-201)

Multi-purpose Dry Batteries ( Classification-R03, R6, R14 and R20 ) - IS 8144

Milk Powder - IS 1165

Processed cereal based complementary foods - IS 11536

Follow-up Formula Complementary Foods - IS 15757

Condensed milk, partly skimmed and skimmed condensed milk - IS 1166

Sweetened ultra high temperature treated condensed milk - IS 12176

Skimmed milk-powder, standard grade - IS 13334 (Part-1)

Skimmed milk-powder, extra grade - IS 13334 (Part -2)

Packaged Natural Mineral Water - IS 13428

Infant milk substitutes - IS14433

Partly skimmed milk powder - IS 14542

Packaged Drinking Water (Other than Packaged Natural Mineral Water) - IS 14543

Milk-cereal based weaning foods - IS 1656

Hexane, Food grade - IS 3470

Plastic Feeding Bottles - IS 14625


Glass Feeding Bottles - IS 5168

Oil pressure stove, offset burner type - IS 10109

Multi-burner oil pressure stoves - IS 2787

Oil pressure stoves - IS 1342

Automotive Vehicles Tubes for pneumatic tyres - IS 13098

Automotive vehicles-Pneumatic tyres for two and three-wheeled motor vehicles - IS 15627

Automotive vehicles-Pneumatic tyres for passenger car vehicles-Diagonal and radial ply - IS 15633

Automotive vehicles-Pneumatic tyres for commercial vehicles-Diagonal and radial ply - IS 15636

Liquefied petroleum gas containers for automotive use - IS 14899

Multifunction valve assembly for permanently fixed liquefied petroleum gas (LPG) containers for automotive use - IS 15100

Welded low carbon steel cylinders exceeding 5 litre Water capacity for low pressure liquefiable gases Part 4 Cylinders for toxic and corrosive gases - IS 3196 (Part-4)

Welded low carbon steel gas cylinder exceeding 5 litre water capacity for low pressure liquefiable gases Part 1 Cylinders for LPG - IS 3196 (Part-1)

Welded low carbon steel gas cylinder exceeding 5-litre water capacity for low pressure liquefiable gases Part 2 Cylinders for liquefiable gases other than LPG - IS 3196 (Part-2)

Valve fittings for compressed gas cylinder excluding liquefied petroleum gas cylinders - IS 3224

Yoke Type Valve Connection for Small Medical Gas Cylinders - IS 3745

Welded low carbon steel cylinders for low pressure liquefiable gases not exceeding 5 litre water capacity - IS 7142

Refillable Seamless steel gas cylinders Part 1 Normalized steel cylinders - IS 7285 (Part-1)

 

Valve fittings for gas cylinder valves for use with breathing apparatus - IS 7302

Welded and seamless steel dissolved acetylene gas cylinders - IS 7312

Valve fittings for use with liquefied petroleum gas cylinders of more than 5 litre water capacity Part 2 Valve fittings for newly manufactured LPG cylinders - IS 8737

Valve Fittings for Use with Liquefied Petroleum Gas (LPG) Cylinders upto and Including 5-Litre Water Capacity - IS 8776

Low pressure regulators for use with liquefied petroleum gas (LPG) mixtures - IS 9798

Clinical thermometers Part 1-Solid stem type - IS 3055 (Part-1)

Clinical thermometers Part 2-Enclosed scale type - IS 3055 (Part-2)

 

Diagnostic Medical X Ray Equipment - IS 7620 (Part-1)

 

Mild Steel and Medium Tensile Steel Bars and Hard-Drawn Steel Wire for Concrete Reinforcement (Part 1) Mild steel and medium tensile steel bars - IS 432 (Part - 1)

Mild steel and Medium Tensile steel bars and Hard-Drawn Steel Wire for Concrete Reinforcement (Part 2) Hard-Drawn Steel Wire - IS 432 (Part - 2)

Stainless Steel Bars and Flats - IS 6603

Bright steel bars-Specification - IS 9550

Specification for High Tensile Steel Bars used in Pre-stressed Concrete - IS 2090

Chrome molybdenum steel bars and rods for aircraft purposes - IS 963

Steel Wire for Nipples for Spokes - IS 8564

Stress-Relieved, Low Relaxation Steel Wire for Pre-stressed Concrete - IS 16644

Trapezoidal Steel Wire for Springs Washers - IS 12262

Plain Hard-drawn Steel Wire For Pre-stressed Concrete Part 1 Cold Drawn Stress-relieved Wire - IS 1785 (Part - 1)

Plain hard-drawn steel wire for pre-stressed concrete Part 2 as drawn wire - IS 1785 (Part -2)

Mild steel wire for cotter pins - IS 10794

Mild steel wire rods for general engineering purposes - IS 7887

Steel Wire for Reeds -IS 8566

Half Round Mild Steel Wire for The Manufacture of Split Pins - IS 8563

Tinned Steel Wire for Banding of Armatures And Rotors Part-3 Specific Requirements for non-magnetic banding wires - IS 8510 (Part - 3)

Steel Wire for Banding Of Armatures And Rotors Part-2 Specific Requirements for magnetic banding wires - IS 8510 (Part - 2)

Hard Drawn Steel Wire for Upholstery Springs - IS 2589

High Carbon Steel Wire Rods - IS 7904

Mild steel wire for General Engineering purposes - IS 280

Round Steel wire for ropes - IS 1835

Low Carbon Galvanized steel wires formed wires and Tapes for armouring of Cables - IS 3975

Steel wire for mechanical springs Part-1 cold drawn unalloyed steel wire - IS 4454 (Part -1)

Steel wire for mechanical springs Part-2 oil hardened and tempered steel wire - IS 4454 (Part -2)

Stainless Steel wire Rod - IS 6527

Specification for Mild Steel Wire, Cold Heading Quality - IS 1673

Specification for Carbon Steel Wire for the Manufacture of Wood Screws - IS 1812

Specification for Mild Steel Wire Rod for the Manufacture of Machine Screws - IS 2255

Specification for Steel Wire for Umbrella Ribs - IS 4223

Specification for Steel Wire for Staples, Pins and Clips - IS 4224

Specification for Steel Wire for spokes - IS 6902

Specification for Steel Wire ( up to 20 mm ) for the manufacture of cold-forged rivets - IS 7557

Steel Cast Billet Ingots, Billets and Blooms for production of High Carbon Steel Wire Rods-Specification - IS 8951

Steel ingots, blooms and billets for production of mild steel wire rods for general engineering purposes-Specification - IS 8952

Specification for Steel Wire for Needles - IS 9962

Specification for Low Carbon Steel Wire for Rivets for use in Bearing Industry - IS 4882

Specification for Hard-drawn Steel Wire Fabric for Concrete Reinforcement - IS 1566

Steel Wires for Mechanical Springs Part-4 Stainless Steel Wire - IS 4454 (Part - 4)

Steel tubes for structural purposes - IS 1161

Steel Tubes, Tubulars and Other Wrought Steel Fittings Part 1-Steel Tubes - IS 1239 (Part - 1)

Steel tubes used for water-wells (upto 200 mm dia) - IS 4270

Fusion bonded epoxy coated reinforcing bars - IS 13620


Galvanized steel sheets (plain and corrugated) - IS 277


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