Introduction
The sale of drugs in India is governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. These regulations ensure that drugs are sold in a controlled and safe manner, preventing misuse and ensuring public health safety. This note provides a detailed overview of the different types of drug sales (wholesale, retail, and restricted license) and the offences and penalties associated with violations of these regulations.
Wholesale Sale of Drugs
Definition
Wholesale sale refers to the sale of drugs to entities that will resell them to consumers or other entities, such as pharmacies, hospitals, or other wholesalers.
Regulatory Framework
1. License Requirements
– Wholesale License: A wholesale license is mandatory for entities involved in the wholesale distribution of drugs. This license is issued by the State Drug Control Authority.
– Application Process: The applicant must submit Form 19 along with the prescribed fee and supporting documents, including details of the premises, storage facilities, and the qualifications of the person in charge.
2. Storage and Premises
– Premises: The premises must be suitable for the storage and distribution of drugs, with adequate space, ventilation, and protection from contamination.
– Cold Storage: Drugs requiring refrigeration must be stored in a cold storage facility to maintain their potency and efficacy.
3. Personnel
– Qualified Staff: The wholesale distributor must employ at least one qualified person (such as a registered pharmacist or a person approved by the licensing authority) to oversee drug storage and distribution.
4. Record-Keeping
– Documentation: Detailed records of all transactions must be maintained, including the source of drugs, quantities received, and quantities sold.
– Retention Period: Records must be retained for at least three years from the date of the transaction.
5. Inspections and Compliance
– Regulatory Inspections: Regular inspections by the Drug Control Authority ensure compliance with regulatory requirements.
– Compliance with Laws: Wholesalers must adhere to all applicable laws and regulations to prevent the sale of counterfeit or substandard drugs.
Retail Sale of Drugs
Definition
Retail sale refers to the sale of drugs directly to consumers by licensed pharmacies and medical stores.
Regulatory Framework
1. License Requirements
– Retail License: A retail license is required for pharmacies and medical stores to sell drugs to consumers. This license is issued by the State Drug Control Authority.
– Application Process: The applicant must submit Form 19 along with the prescribed fee and supporting documents, including details of the premises, storage facilities, and the qualifications of the person in charge.
2. Storage and Premises
– Premises: The retail premises must be suitable for the storage and sale of drugs, with adequate space, ventilation, and protection from contamination.
– Cold Storage: Drugs requiring refrigeration must be stored in a cold storage facility to maintain their potency and efficacy.
3. Personnel
– Registered Pharmacist: The retail pharmacy must employ a registered pharmacist to oversee drug storage and dispensing.
– Training: Staff must be trained in handling, dispensing, and advising on the proper use of drugs.
4. Record-Keeping
– Prescription Records: Detailed records of all prescription drugs sold must be maintained, including the name of the prescriber, the patient, the drug, and the quantity dispensed.
– Retention Period: Records must be retained for at least three years from the date of the transaction.
5. Inspections and Compliance
– Regulatory Inspections: Regular inspections by the Drug Control Authority ensure compliance with regulatory requirements.
– Compliance with Laws: Retailers must adhere to all applicable laws and regulations to prevent the sale of counterfeit or substandard drugs.
Restricted License
Definition
A restricted license is issued for the sale of certain specified categories of drugs, usually under specific conditions and limitations.
Regulatory Framework
1. License Requirements
– Restricted License: This license is required for entities that do not qualify for a full wholesale or retail license but are permitted to sell certain categories of drugs.
– Application Process: The applicant must submit the prescribed application form along with the fee and supporting documents as required by the licensing authority.
2. Conditions and Limitations
– Specified Drugs: The license will specify the categories of drugs that can be sold under the restricted license.
– Special Conditions: The licensing authority may impose special conditions regarding the storage, sale, and record-keeping of these drugs.
3. Storage and Premises
– Premises: The premises must be suitable for the storage and sale of the specified drugs, with adequate space, ventilation, and protection from contamination.
4. Personnel
– Qualified Staff: The restricted license holder must employ qualified personnel to oversee drug storage and distribution as per the conditions specified in the license.
5. Record-Keeping
– Documentation: Detailed records of all transactions must be maintained, including the source of drugs, quantities received, and quantities sold.
– Retention Period: Records must be retained for at least three years from the date of the transaction.
6. Inspections and Compliance
– Regulatory Inspections: Regular inspections by the Drug Control Authority ensure compliance with regulatory requirements.
– Compliance with Laws: License holders must adhere to all applicable laws and regulations to prevent the sale of counterfeit or substandard drugs.
Offences and Penalties
Offences
1. Manufacture, Sale, or Distribution of Substandard Drugs
– Manufacturing, selling, or distributing drugs that do not meet prescribed standards of quality.
2. Sale without a Valid License
– Selling drugs without obtaining the required licenses from the regulatory authorities.
3. Misbranding or Mislabeling
– Selling drugs with false or misleading labeling or packaging.
4. Adulteration
– Mixing or substituting drugs with inferior or harmful substances.
5. Sale of Banned Drugs
– Selling drugs that have been banned by regulatory authorities.
6. Non-compliance with Regulatory Requirements
– Failing to comply with the conditions of the license or other regulatory requirements, such as record-keeping and storage conditions.
Penalties
1. Fines
– Monetary penalties imposed for various offences, with the amount depending on the severity of the violation.
2. Imprisonment
– Imprisonment for severe offences, such as the sale of adulterated or spurious drugs.
3. Suspension or Cancellation of License
– Regulatory authorities may suspend or cancel the license of entities found guilty of serious violations.
4. Product Recalls
– Mandatory recalls of drugs found to be substandard, misbranded, or adulterated.
5. Prohibition Orders
– Orders prohibiting the sale or distribution of certain drugs until compliance is ensured.
Specific Penalties Under the Drugs and Cosmetics Act
– Section 27: Imprisonment for not less than ten years and a fine of not less than ten lakh rupees for the manufacture, sale, or distribution of spurious or adulterated drugs likely to cause death or severe harm.
– Section 27A: Imprisonment for up to five years and a fine for the manufacture, sale, or distribution of drugs without a valid license.
– Section 28: Imprisonment for up to two years and a fine for the misbranding or mislabeling of drugs.
– Section 28A: Imprisonment for up to two years and a fine for the manufacture, sale, or distribution of drugs not of standard quality.
Conclusion
The sale of drugs, whether wholesale, retail, or under a restricted license, is subject to strict regulatory controls to ensure the safety and efficacy of pharmaceutical products. Compliance with the Drugs and Cosmetics Act and the associated rules is essential to prevent the sale of substandard, misbranded, or adulterated drugs. Offences under these regulations are met with severe penalties, including fines, imprisonment, and license suspension or cancellation. By adhering to these regulations, stakeholders in the pharmaceutical industry can contribute to public health and safety.
