Understanding Narcotics Control, Drug Import, and Manufacturing Regulations in India

Posted on Apr 6, 2025 in Other university degrees and diplomas

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 Alcohol: Alcohol is ethyl alcohol of any concentration and purity having the chemical composition C2H5OH.

Excise Officer: It is an officer of the excise department of any state and includes any person empowered by the collecting government to exercise any of the powers of an excise officer under this act.

Medicinal Preparation: Including all drugs which are prescription prepared for external and internal use of human beings or animals in treatment, reduction, and prevention of disease.

Narcotic Drugs: Those substances which are coca derivatives, opium, or Indian hemp and shall include any other substance which produces dependence, tolerance, and withdrawal syndrome in human beings.

Toilet Preparation: This act was passed to collect tax and duties of excise imposed on medicinal and toilet preparations made up of alcohol and other narcotic drugs. 


Narcotics Control Bureau (NCB)

  • NCB was established on 17th March 1986 to enable the full implementation of the NDPS Act 1985.
  • Headquarter: Delhi
  • NCB is the chief law enforcement and intelligence agency of India.

Authorities and Officers:

  1. Central government to take measures for preventing and combating abuse of narcotic drugs and illicit traffic therein.
  2. Officers of Central Government
    • They appoint Narcotic Commissioner and other officers.
    • The functions are:
      1. The supervision of cultivation of opium poppy
      2. Production of Opium.
  3. NDPS Consultative Committee. The committee shall advise the central government on matters relating to the administration of the Act.

Prohibition, Control, and Regulation: No person with the permission of the central government shall:

  1. Cultivate coca plant or gather any portion of it.
  2. Cultivate opium poppy or cannabis.
  3. Produce, manufacture, sell, purchase, transport, warehouse, use, import, and export NDPs except for medicinal and scientific purposes with government approval.

Psychotropic Substances: Any natural or synthetic drug that affects emotional state includes:

  1. Antidepressants
  2. Sedatives
  3. Stimulants
  4. Tranquilizers

Offences:

  • Contravention of provisions in respect of poppy plant opium and coco plant prepared opium, manufactured drugs, and narcotics.
  • Illegal import or export or external dealings in NDPs.
  • Allowing use of premises and vehicles for commission of an offence under the Act.
  • Embezzlement of opium by licensed cultivators.
  • Contravention in respect of cannabis plant other than GANJA.

Penalties:

  • Rigorous imprisonment for 10-20 years and a fine between ₹ 1 to 2 lakhs or more.
  • Rigorous imprisonment up to 5 years and fine up to ₹ 50000.


Import of Drugs in India

  • The Central Government exercises regulatory control over drugs and cosmetics imported into the country through the Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI).
  • The manufacture, sale, and distribution of drugs are primarily regulated by the State Drug Control Authorities appointed by the State Government.
  • The objective of the drug regulatory system in the country is to ensure the availability of safe, effective, and quality drugs, cosmetics, and medical devices based on scientific excellence and best possible regulatory practices.
  • Drug is defined in Section 3 of the Drugs and Cosmetics Act 1940. The Central Government has the power to declare any drugs, cosmetics, or medical devices as useful Drugs by giving notification in the official gazette.
  • By virtue of the said power, the Central Government has Notified Disposable Hypodermic Syringe, Disposable Hypodermic Needle, and Orthopedic Implant, Catheter, as drugs in 1989.

There are three types of import:

  1. Registered Drugs (Import under license or permit)
  2. Unregistered Drugs
  3. Import of Excipient

Import of Registered Drugs (Import under license or permit)

  • When any drug is registered in India, a Certificate of Registration in the prescribed Form 41 is issued by the appropriate authority of the Central Government. When any person wants to import the registered drug, they are required to have import licenses by the appropriate authorities of the Central Government.

Import of Unregistered Drugs

  • An unregistered drug means a drug which is not registered in India; hence, no import license is issued consequently. The import of unregistered drugs in India is not possible. However, various Drug Manufacturers Associations have granted exemptions from registration requirements under the Drugs and Cosmetics Act.

Import of Excipient

  • When importing any drug, some substance is used for coloring or as a preservative or as a filler or diluter. The substance is not active in the drug in which it is used but works as a vehicle or medium for the drug or other active substances. This substance which is so used is called an excipient.


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Manufacturing Under Loan Licenses

  1. Application must be supported by the parent firm.
  2. Drug inspector inspects the premises of the parent firm and checks and assesses the spare capacity.
  3. A loan license is required to test each batch of raw materials and finished products. Records of testing should be maintained for 5 years or 2 years in the case of expiry drugs from such data.
  4. Patent medicines must be safe for use in the context of vehicle and additives.
  5. The production must be supervised by a competent person of the loan licensee.

License for Repacking

The application is made for grant or renewal of a license in Form 24-B. The license is issued by the Licensing Authority after inspection in Form 25-B. The process of breaking up any drug from its bulk container into small packages and labeling with a view to their sale and distribution is done under a repacking license. It is issued for drugs other than Schedules C, C1, and X, subject to fulfillment of conditions.

Procedure:

Conditions:

  1. Adequate space and equipment should be provided.
  2. Hygienic conditions of working should always be maintained.
  3. Repacking should be supervised by a competent person.
  4. There should be adequate arrangement for testing of samples.
  5. The license should always be displayed at the premises of repacking.
  6. The factory premises for repacking should comply with provisions of Schedule M.
  7. Adequate staff should be appointed, and any change in staff structure should be immediately informed to the Controlling Authority.
  8. The container or package of repacked drug should bear on its label the words – “Rpg.Lic.No”.

The license is valid till 31st December every year and required to be renewed. There should be a separate application for a separate license. 


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The license specifications are the same for the manufacturing of medicinal preparations outside bond and inside bond. 

  • Non-bonded manufacturing requires separate premises where only Medicinal and Toilet Preparations will be manufactured.

License: 

  • The license required for manufacturing Medicinal and Toilet Preparations without bond can be obtained by giving an application to officers appointed by the state government.
  • The application form and other conditions of the license for manufacturing Medicinal Preparation outside bond (Non-bond) are the same as those for manufacturing under bond. 

Offences and Penalties

Sr. Offences Penalties

1. Non-compliance with condition of license and failure to pay duty. | Imprisonment for up to 6 months or fine up to 200 or both.

2. Failure of excise officer on duty. | Imprisonment for up to 3 months fine up to 2000 or both.

3. Improper keeping of stocks or accounts | Fine up to 100

4. Making fake entries are tearing pages from stock books | Fine up to 100

5. Failure to furnish proof of export within specify period | Fine up to 2000.