Central Drugs Standard Control Organization (CDSCO)
The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
Under the CDSCO, following are the divisions:
- New Drugs: Demonstration of safety and efficacy of the drug product for use in humans.
- Import and Registration: The import of Drugs into India is regulated under Drugs & Cosmetics Act 1940
- Medical Device & Diagnostics: Only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules which are required license under the Act.
- Cosmetics: Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under, the manufacture of cosmetics is regulated.
- Bioavailability/Bioequivalence: To carry out BA/BE studies with various pharmaceutical dosage formulations, applicant has to request for approval from Drugs Controller General (India).
- Biologics
- Clinical Trials
- DCC-DTAB
Medical Device & Diagnostics:
Notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945 which requires license under this Act to be manufactured for sale or for distribution or importing such medical device.
We Osgan, offers comprehensive services and assists in preparing application in accordance with the regulatory framework based on the Medical Device Rules. With the exhaustive knowledge and experience of our team, we shall advise the applicability under the relevant class and hand hold your team from registration till issuance of the license.
Cosmetic License:
Cosmetic is defined under section 3(aaa) of the Drugs and Cosmetics Act, 1940 as, any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance, and includes any article intended for use as a component of cosmetic.
For all the entities dealing in cosmetics in India has to take mandatory approval under the Drugs and Cosmetics Act. The license requirement is for all the 3 categories:
- Manufacturer of the Cosmetics
- Loan licence for the manufacture
- Importer of Cosmetics
We Osgan, offers detailed advice on the applicability and procedure for application and issuance of the license of Cosmetic Manufacturing/import.
Our team of experts offers extensive support and handholding to the companies in assistance in preparing the application, co-ordination with the department till issuance of the license.
PESO Certification
Petroleum and Explosives Safety Organization (PESO) under the Ministry of Commerce and Industry has been given the responsibility for regulating safety of hazardous substances such as explosives, compressed gases and petroleum.
To oversight the products falling under explosives products, pressure vessels, gas cylinders, petroleum, the manufacturer, transporter, importer or trader has to ensure the safety of these hazardous products.
PESO organisation is headquatered in Nagpur, Maharashtra and outlines the approval process which is mandatorily required by the following businesses:
- Explosives
- Petroleum
- Gas Cylinders
- Pressure Vessels
We Osgan Consultants facilitate clients in obtaining the Explosive License/ NOC for storage, manufacturing of compressed gases, Petroleum Products and explosives.
We assist in preparation of the application, representation to the department till the final approval by the PESO office.
Legal Metrology Act
To ensure public guarantee from the point of view of security and accuracy of the weighments and measurements, Legal Metrology Act was introduced. The act provides standardization of units of weights and measures based on metric system.
Rules under Legal Metrology Act
Legal Metrology (General) Rules, 2011: The rules prescribe weighing and measuring instruments specifications which the Manufacturer has to conform with the specifications mentioned under the Rules.
Legal Metrology Approval of Models Rules: Manufacturers/ Importers of Weighing and Measuring equipment, prescribed Under the Legal Metrology Act, 2009, are required to take approval under this Act before manufacturing/ import.
To ensure every weight and measure produced is similar and conform the characteristics and qualities as provided in the Act, an application for approval of the model has to be made to the Director.
Legal Metrology National Standards Rules 2011: The rules provide units of weight or measure to be based on metric system.
Registration under Legal Metrology Act
Every Manufacturer, Repairer or Dealer of weights and measures is required to obtain a license under the Legal Metrology Act which will be issued by the Controller of Legal Metrology.
The application has to be submitted to the district nodal official after which the Inspector shall inspect the premise of the applicant to verify the compliance with the Act.
Legal Metrology (Packaged Commodities) Rules
The Rules is applicable for “Pre-packaged Commodity” which is defined as a commodity which without the purchaser being present is placed in a package of whatever nature, whether sealed or not, so that the product contained therein has a pre-determined quantity.
Every package shall bear a definite, plain and conspicuous declaration as mentioned in the Rules with the manner and appearance.
Every individual, firm, HUF, Society, Company or corporation who pre-packs or imports any commodity for sale, distribution or delivery shall make an application to the Director for the registration.
We Osgan QCMS have extensive experience for providing registration under Legal Metrology Act & Rule. Our qualified team assists from the documents requirement, collation of documents, preparation of application till issuance of registration under the Act.
