Drug Distribution, Sale and Manufacture under the Drugs and Cosmetics Act

 

Page Contents

 

• Restrictions on Manufacturing, Sale, and Drug Distribution

• Standard Quality of Drugs and Cosmetics

• Following are the Restricted Drugs and Cosmetics

• Misbranded Drugs and Misbranded Cosmetics

Adulterated Drugs and Adulterated Cosmetics

• Spurious Drugs and Spurious Cosmetics

• Prohibition of Drug Manufacture for Sale or Drug Distribution

• Manufacturer

  • Persons bound to disclose Place where Drugs or Cosmetics are manufactured

• Maintenance of Records and furnishing of information

• Penalty for Manufacture, Sale, or Drug Distribution in Contravention to Act

• Penalty for Manufacture, Sale, or Distribution of Cosmetics in Contravention to Act

• Conclusion

 

 

 

Drugs and cosmetics fall into the list of ingredients that must be handled delicately. While it may be a life-saving remedy, it may also be prohibited for inappropriate use. This prompts requires a regulation that is regulated by the Drugs and Cosmetics Act of 1940 in India. This article explores the rules regarding the distribution, manufacture, and sale of drugs under the Drugs and Cosmetics Act 1940.

Restrictions on Manufacturing, Sale, and Drug Distribution

 

The following drugs are prohibited from being manufactured for sale or from being offered for sale or for drug distribution As per the Drugs and Cosmetics Act:

 

Standard Quality of Drugs and Cosmetics

 

The Standard Quality of drugs means that drug which complies with the grade set out in the Second Schedule, and that cosmetics which complies with such standards as prescribed in the same schedule. The Central Government, after advice with the Drugs Technical Advisory Board, can amend the second schedule. The government after giving three months of notice of its intention to do so can amend accordingly by making a notification in the Official Gazette.

 

Following are the Restricted Drugs and Cosmetics

 

Misbranded Drugs and Misbranded Cosmetics

 

if a drug is colored, coated, powdered, or polished to conceal the damaged, then the Drug is deemed to be misbranded as per under Section-17.

 

The drug is also called misbranded if:

 

• Really appears to be the presence of a better or greater therapeutic value than this or if it is not labeled in the prescribed manner

• Its label or container or anything associated with the drug carries a statement, design, or device that makes a false claim for the drug or is particularly false or misleading

 

Misbranded Cosmetics referred to under Section 17-C is called misbranded if:

 

• It contains a color that is not specified or if it is not labeled in the prescribed manner

• Labels or containers or cosmetics carry any statement that is particularly false or misleading

 

Adulterated Drugs and Adulterated Cosmetics

 

The Adulterated Drugs as specified under Section 17-A and The Adulterated Cosmetics referred to under Section 17-E is called to be adulterated if:

• It consists in whole or in part of any dirty, filthy, or rotten substance.

• It has been prepared, packaged, and stored under unhealthy conditions that may contaminate with grime or it may have been rendered harmful to health.

• Its container is composed entirely or partially of any toxic or harmful substance which may provide harmful substances for health.

• It carries or contains, for the sole purpose of coloring, any color other than the prescribed color

• It contains any harmful or toxic substances that can be harmful to health

• Any substance has been mixed with it to reduce its quality or strength

 

Spurious Drugs and Spurious Cosmetics

 

The Spurious Drugs as specified under Section 17-B and The Spurious Cosmetics as referred under Section 17-D is called to be spurious if:

• It is manufactured under a name that belongs to other drug or cosmetic

• It is an emulation of or is a substitute for; other drugs or cosmetics became like another drug or cosmetics in a manner likely to deceive. If it is clearly marked such that it fails to disclose its true character or its lack of identity with such other drugs or cosmetics.

• The label or container carry the name of a person or organization purporting to be the manufacturer of the drug, which individual or company is imaginary or non-existent

• It has been substituted entirely or in part by another drug or cosmetic

• It plans to be a product of a manufacturer with whom it is not really a product

 

Drug Manufacture Prohibition for Sale or Drug Distribution

 

Under Article 18, the person does not sell, distribute, sell, or make offers for stock or exhibitions or sales or distribute some prohibited drugs or cosmetics to or on behalf of any person.

 

Those are as follows:-

 

• Any drug that is not of a standard quality, or is misbranded, adulterated, or spurious

• Any cosmetic that is not of standard quality or is misbranded or spurious

• Any patent or proprietary medicine, unless displayed in the manner specified on its label or container

• Any drug that purports or claims to prevent, cure or mitigate any disease or ailment

• Any drug or cosmetic which is manufactured in contravention of the conditions mentioned

• Cosmetics that contain any ingredients that make it unsafe or harmful to use

• Any drug or cosmetics business without complying with the provisions of this Act

• Offer, or distribute for sale or stock or display or sale of any medicine or cosmetics imported or manufactured in violation of any provision of this Act

• Manufacture for sale or for drug distribution, any drug or cosmetic, without in accordance with the conditions of, a Manufacture drug license issued for such object under this Act.

 

The prohibition has exclusion under the following situations:

 

• This provision does not apply to the production of small quantities of any drug for the purpose of testing, analysis, or examination under certain conditions.

• The Technical Advisory Board of Drugs may, in consultation with the Central Government, grant permission for sale or distribution, sale, stockpiling, or sale or distribution or sale of drugs without disclosing the quality or value of the drug.

 

Manufacturer

 

Under section 18, if necessary, is responsible for disclosing the name, address, and other details of the person from whom the drug or cosmetics were obtained. This provision makes exceptions to licensed manufacturers for the distribution of drugs or cosmetics or its agents.

Individuals forced to express space where drugs or cosmetics are produced

Under section 24, the person in charge of any premises, for the time being, must be informed to the inspector that any drug or cosmetics are being prepared for sale or kept for drug distribution. He is also legally obliged to disclose any other information to the inspector about the place where the medicine or cosmetics are being made or kept.

 

PENALTY	confinement	FINE
The Penalty is given Under Section 28 for Non-Disclosing of the name of the manufacturer	Anyone violating the provisions of Section 16 or Section 24 must be punished with imprisonment which may be extended for one year.	Not less than twenty thousand rupees.
The Penalty is given Under Section 28- A for not Keeping Documents and for Non-Disclosing of Information	Violators of the provisions of Section 1 16 or Section 24 must be imprisoned which may be extended for one year.	Not less than twenty thousand rupees.

 

 

Maintenance of Records and furnishing of information

 

Under Section 18-B, the person carrying a license of drugs and cosmetics must keep and sustain such records, registers, and other documents concerning drugs and cosmetics or as may be prescribed. He must provide such information to any officer or authority exercising any power or discharging any function under this Act as is required by such officer or authority for carrying out the objective of this Act.

This information must be provided to any officer or authority exercising any power or enforcing any law under this Act for the purpose of this Act.

 

Punishment for Manufacture, Sale, or Drug Distribution in breaking to Act

 

• Any drug that is considered to be adulterated under section 17-A or spurious under section 17-B or when the drug is adulterated or spurious or not of standard quality is used by any other person causes his death or troublesome hurt, then he must be punishable with confinement for a term which shall not be less than ten years and can extend to a term for life. He must also be responsible for the fine which must not be fewer than ten lakh rupees or three times worth of the drugs confiscated, whichever is more.

1. The person guilty under this section must pay compensation to the person who has used the adulterated or counterfeit drugs referred to in this section.

 

1. If the person dies after the use of adulterated or counterfeit drugs mentioned in this section, the guilty person must pay to the relative of the deceased who died due to the use of adulterated or counterfeit drugs.

• Any drug that is deemed to be adulterated under section 17A, other than a drug mentioned to in clause (a) used without a valid license as necessary under this Act must be punishable with imprisonment for a term which must not be less than three years and can reach to five years. He will be liable for fines not less than one lakh rupees or three times the value of the seized drugs, whichever is higher.

1. The Court may after mentioning any enough and particular cause in the judgment can impose a sentence of imprisonment for a term of fewer than three years and a fine of less than one lakh rupees

• Except for the drugs referred to in clause (a), any drug deemed to be unnecessary under section 1-B shall not be less than seven years in prison and may be sentenced to imprisonment for a term not exceeding life imprisonment. He must be held accountable for good deeds which are not three times or three times less than the value of the seized drugs, anymore.

1. The Court may after looking any enough and special reasons in the judgment can impose a sentence of imprisonment for a term of fewer than seven years but not less than three years and of a fine of fewer than three lakh rupees

Any drug other than the drugs referred to in Clause (a) or Section (b) or Section (c) in violation of any other provision or any rule of this Act, made thereunder, must be punishable with imprisonment for a term which must not be less than one year and can extend to two years. He must be liable for a fine which must not be less than twenty thousand rupees

1. The Court may after mentioning any adequate and special reasons in the judgment can impose a sentence of imprisonment for a term of less than one year.

 

Punishment for Manufacture, Sale, or Distribution of Cosmetics in violation of Act

 

Under Section 27-A, anyone who sells or distributes drugs on his own behalf or to any other person, or sells, or offers to sell stock or exhibitions or sales, may be punished in the following circumstances:

• Any cosmetics that are considered to be counterfeit under Article 17-D or adulterated under Article 17-E must be punishable by imprisonment for a term Which can be increased within three years and a fine which is less than fifty thousand rupees or not more than three times the value of the forfeit cosmetics, anymore.

• Any cosmetic other than a cosmetic referred above if in contravention of any provisions of this Act or any rule made thereunder must be punishable with imprisonment for A term that can be extended with one year or a fine which can be increased to twenty thousand rupees or both.

 

Conclusion

 

License for drug distribution, manufacture, and sale requires conditions to be fulfilled as Licensee must have an adequate storage facility, and the applicant must be reputable in the occupation. The drug license granted for any of the above must not be suspended or canceled unless the licensee has not been convicted any offense under the Drugs and Cosmetics Act 1940