Drugs and Cosmetics Act: Drugs Inspector & Import Regulations - Download PDF
Delve into critical aspects of the Drugs and Cosmetics Act, 1940, with this resource focusing on the Drugs Inspector and import regulations. Download our detailed PDF, notes, and PPT to understand the qualifications, functions, and duties of a Drugs Inspector. Additionally, explore the provisions governing the import of drugs under license, and the specific procedures for the import and registration of both drugs and cosmetics in India.
This content is essential for aspiring Drugs Inspectors, pharmacy students, regulatory affairs professionals, and businesses involved in the import of pharmaceutical and cosmetic products. Download for comprehensive offline study or view online.
Key Topics Covered:
- Qualifications, functions, and duties of a Drugs Inspector as per the D&C Act.
- Provisions for the import of drugs under license, including types of licenses and conditions.
- Procedures and requirements for the import and registration of drugs.
- Procedures and requirements for the import and registration of cosmetics.
Keywords:
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DRUGS AND COSMETICS ACT: Drugs Inspector, Import & Registration Provisions
The Drugs and Cosmetics Act, 1940, and its Rules, 1945, establish a robust framework for ensuring the quality, safety, and efficacy of drugs and cosmetics in India. Key components of this framework include the role of Drugs Inspectors in enforcement and specific regulations governing the import of these products. This discussion will cover the qualifications, functions, and duties of Drugs Inspectors, alongside the provisions for importing drugs under license and the registration requirements for drugs and cosmetics.
Drugs Inspector: Qualifications, Functions, and Duties
Drugs Inspectors are pivotal public servants appointed by the Central or State Government under Section 21 of the Act. They are the primary enforcement officers at the ground level.
Qualifications of a Drugs Inspector (Rule 49):
A person to be appointed as a Drugs Inspector generally needs to possess:
- A degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in Clinical Pharmacology or Microbiology from a University established in India by law; OR
- If appointed for inspection of manufacture of substances specified in Schedule C:
- For biological products (other than Homoeopathic): A graduate in Pharmacy or Pharmaceutical Chemistry or Medicine or Science or Chemical Engineering or Chemical Technology, with at least 18 months' experience in the manufacture of at least one of the substances specified in Schedule C.
- For veterinary biological products: A graduate in Veterinary Science or general Science or Medicine or Pharmacy, with specialized training or experience in veterinary biologicals.
- Other specialized requirements exist for specific types of Schedule C and C(1) drugs.
- No financial interest in the import, manufacture, or sale of drugs or cosmetics.
Training and experience requirements may also be stipulated.
Functions and Duties (Powers) of a Drugs Inspector (Section 22):
Subject to the provisions of Section 23 (Procedure of Inspectors) and any rules made by the Central Government, a Drugs Inspector may, within the local limits for which he is appointed:
- Inspect:
- Any premises wherein any drug or cosmetic is being manufactured, and the means employed for standardizing and testing the drug or cosmetic.
- Any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed.
- Take Samples:
- Take samples of any drug or cosmetic which is being manufactured or being sold or is stocked or exhibited or offered for sale, or distributed. Payment for the fair price of the sample is usually required.
- Search and Seize:
- Search any person, who he has reason to believe has secreted about his person, any drug or cosmetic in respect of which an offence under this Chapter has been, or is being, committed.
- Enter and search, at all reasonable times, with such assistance, if any, as he considers necessary, any place in which he has reason to believe that an offence under this Chapter has been or is being committed.
- Stop and search any vehicle, vessel or other conveyance which, he has reason to believe, is being used for carrying any drug or cosmetic in respect of which an offence under this Chapter has been or is being committed.
- Order in writing the person in possession of the drug or cosmetic in respect of which the offence has been or is being committed, not to dispose of any stock of such drug or cosmetic.
- Seize such drug or cosmetic and all materials or articles used in the manufacture thereof and all other articles which he has reason to believe may furnish evidence of the commission of an offence punishable under this Act or the Rules made thereunder.
- Seize any record, register, document or other material object found in any place if he has reason to believe that it may furnish evidence of the commission of an offence.
- Examine Records: Require any person to produce any record, register, or other documents relating to the manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or distribution of any drug or cosmetic in respect of which he has reason to believe that an offence under this Chapter has been or is being committed.
- Exercise other prescribed powers: Such other powers as may be necessary for carrying out the purposes of this Chapter or any rules made thereunder.
Duties also include investigating complaints, launching prosecutions for violations of the Act, and ensuring overall compliance with drug laws in their jurisdiction. They act as a crucial link between the regulatory authorities and the pharmaceutical trade/industry.
Provisions for Import of Drugs Under License (Chapter III of the Act & Part IV of the Rules)
The import of drugs into India is strictly regulated to ensure that only safe, effective, and quality drugs enter the country. No drug can be imported except under a license or by specific exemption.
- Prohibition of Import of Certain Drugs (Section 10): The Act prohibits the import of:
- Any drug which is not of standard quality (misbranded, spurious, adulterated).
- Any misbranded or spurious cosmetic.
- Any drug or cosmetic for the import of which a license is prescribed, otherwise than under, and in accordance with, such license.
- Any patent or proprietary medicine without true formula or list of active ingredients.
- Any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed (referring to Schedule J).
- Any cosmetic containing any ingredient which may render it unsafe or harmful.
- Any drug or cosmetic the import of which is prohibited by rule under this Chapter.
- Import Licenses: Different forms of licenses (e.g., Form 10 for general drug import, Form 10-A for Schedule X drugs) are required depending on the class of drugs being imported. Applications are made to the licensing authority (usually CDSCO).
- Conditions for License: Licenses are granted subject to various conditions, including premises requirements, maintenance of records, and adherence to quality standards. The importer must have adequate storage facilities.
- Import of Drugs for Personal Use: Small quantities of drugs for personal use may be imported under certain conditions, often without a formal license but subject to specific provisions.
- Import for Examination, Test or Analysis: Small quantities of drugs can be imported for these purposes with permission (e.g., in Form 11).
- Import of New Drugs: Requires prior permission from the DCGI after establishing safety and efficacy, often involving clinical trial data generated in India (as per Schedule Y).
Provisions for Import & Registration of Drugs & Cosmetics
Import and Registration of Drugs:
The Drugs and Cosmetics Rules (specifically Part IV and rules like 21, 23, 24, 27, 30-AB, and Chapter IVA - Rules 43A, 43B concerning registration) outline the detailed procedure.
- Registration Certificate (Rule 24A, Form 41): Before importing drugs into India, the overseas manufacturer and the premises where the drugs are manufactured must be registered with the licensing authority (CDSCO). The Indian importer/agent applies for this registration.
- Import License (Form 10/10-A): Subsequent to obtaining the registration certificate for the manufacturer and site, an import license is required for each consignment or for a specified period.
- Application Process: Involves submitting detailed dossiers including manufacturing site details (e.g., Site Master File), drug quality information (e.g., Certificate of Pharmaceutical Product - CoPP, Free Sale Certificate), stability data, manufacturing process, analytical methods, and sometimes inspection of the overseas manufacturing site by Indian regulatory officials.
- Fees: Prescribed fees are payable for registration and import licenses.
- Labeling and Packaging: Imported drugs must comply with Indian labeling and packaging requirements.
Import and Registration of Cosmetics (Part XIII of the Rules):
The regulation of cosmetic imports has been strengthened over the years to ensure consumer safety.
- Registration Requirement (Rule 129C, Form 42 for application, Form 43 for certificate): No cosmetic shall be imported into India unless the product is registered by the Central Licensing Authority (CDSCO). A single application can be made for any number of brands manufactured at one or more locations by a single manufacturer.
- Application for Registration: The manufacturer itself or its authorized agent in India or a subsidiary in India can apply for the registration certificate. The application includes:
- Cover letter from the applicant.
- Form 42, duly filled, signed, and stamped.
- Treasury Challan for the prescribed fee.
- Power of Attorney by the manufacturer to the Indian agent.
- Details of the manufacturer and manufacturing site.
- Product information (brand names, product category, variants).
- Label and pack-shot of the cosmetic.
- Free Sale Certificate or manufacturing license from the country of origin.
- Declaration of non-animal testing (for certain categories).
- Other specific documents as required.
- Conditions for Registration: The imported cosmetics must conform to the standards laid down in the Ninth Schedule of the Cosmetics Rules, 2020 (which has superseded certain parts of D&C Rules for cosmetics). The product should be safe for use and not contain prohibited substances.
- Labeling: Must comply with Indian labeling rules for cosmetics, including details like manufacturer's name and address, country of origin, ingredients, net content, batch number, manufacturing date, expiry date (if applicable), and importer's details.
- Sampling and Testing: Customs officials or Drugs Inspectors may draw samples of imported cosmetic consignments for testing to ensure compliance.
These provisions for Drugs Inspectors and import/registration collectively ensure that drugs and cosmetics entering or circulating within India meet the necessary standards of safety, quality, and efficacy, protecting public health from substandard, spurious, or harmful products.
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