Introduction
India has an emerging market in pharmaceuticals, medical device and cosmetics. The government is very stringent in regulating these sectors as a way of safeguarding the health of the people and product safety. CDSCO is one of the most important regulatory bodies that performs this control.
The sale or importation of regulated products without the due CDSCO approval may result in harsh penalties as fines, imprisonment, seizure of products, and license termination.
This blog describes the definition of CDSCO, the products that have to be approved, the repercussions of not doing so and how companies can escape the legal consequences.
What is CDSCO?
The national drug control regulatory body of India is the Central Drugs Standard Control Organisation (CDSCO). It is under the Ministry of Health and Family Welfare.
CDSCO is responsible for:
Approval of new drugs
Medical devices regulation.
Appendage of cosmetics imports.
Licensing drugs and devices imports.
Clinical trial approvals
Quality and safety assurance.
CDSCO is headed by the Drugs Controller General of India (DCGI).
Which Products Require CDSCO Approval?
Before the sale of some products in India by the manufacturers, the same products must first be approved/certified/registered by CDSCO, as is the case with new drugs, prescription drugs that are subject to the Drugs and Cosmetics Act and its regulations, through;
1) Pharmaceuticals - New Drug Approval Process of Prescription Drugs, Vaccines and other Biologics.
2) Medical Devices - Medical Device Rules CDSCO has made Medical Device Rules 2017, which include:
- Surgical instruments;
- Diagnostic Tests;
- Surgical implants;
- Blood Monitoring Devices;
- Cardiac Stents.
3) Cosmetics (Imported) - Imported cosmetics must first get registered with CDSCO before selling in India.
4) Clinical Trial Products - Investigational products must receive CDSCO Approval to conduct a clinical trial.
Why is CDSCO Approval Important?
CDSCO approval ensures:
Product safety
Quality control
Compliance with Indian standards
Protection of public health
Legal market entry
Selling products without approval not only violates the law but also exposes businesses to criminal liability.
Penalties for Selling Medical Devices without CDSCO Approval
Selling medical devices not approved or licensed by the FDA may result in:
Seizure of Items
Governmental authorities may confiscate the devices without delay.
A revocation of your manufacturing or importing license
Your license to manufacture or import medical devices may be revoked and/or suspended.
Heavy fines
Depending on the severity of the violation, you may receive monetary penalties.
Prison time
If you violate the Drug and Cosmetic Act and endanger the public by distributing an unsafe or counterfeit device, you could serve anywhere from 1 year to a life sentence, depending on your offence.
Penalties for Selling Products without CDSCO Approval
If a company produces, sells, and/or distributes pharmaceuticals without the proper licensing:
Criminal charges could be brought against you
Incarceration and/or large fines may be imposed
Products may be seized by the federal government for destruction
Your facility may be closed and secured
The penalties for producing and/or selling counterfeit or tainted drugs and injuring/destroying someone's life can be life in federal prison and substantial fines.
Penalties for Selling Cosmetics Without CDSCO Approval
Importing cosmetics that do not have their appropriate registration with the Central Drugs Standard Control Organisation of India is at risk for several reasons:
Confiscation of items at customs
An Import Ban
Monetary Penalty
Prosecution under the Drugs and Cosmetics Act of 1940.
If found to be in breach of any of the above regulations multiple times, an importer will be black-listed.
Penalties for Importing Products Without CDSCO Approval
The importation of Drugs, or Cosmetics without the appropriate regulatory approvals may also result in related sanctions:
Seizure of items by Customs authorities
Suspension of an Import Export Code (IEC)
Prosecution under the Drugs and Cosmetics Act of 1940
Cancellation of future import licenses.
Customs authorities collaborate with CDSCO to prevent the importation of illegal items into India.
How to Avoid Penalties for Non-Compliance?
To prevent fines, businesses must:
1. Perform due diligence concerning regulations before launching a product
2. Determine if their product is subject to regulations set forth by CDSCO
3. Obtain the appropriate licenses for manufacturing or importing
4. Make sure their labelling and packaging comply with all applicable regulations
5. Keep records of their quality control processes
6. Hire a regulatory consultant as needed
The cost of compliance is much less than the cost of litigation or fines.
How to Obtain CDSCO Approval?
Basic Steps for Registration of Products in India
- Determine Product Type/e.g., Drug/Device/Cosmetic
- Complete an online application using the CDSCO (Central Drug Standard Control Organisation) SUGAM.
- Provide all required supporting documentation (e.g. product details/manufacturing license/quality certificates/test report/power of attorney for importers)
- CDSCO reviews the product's safety/effectiveness/compliance with regulatory requirements.
- Approval from CDSCO (if granted) will result in the issuance of a registration certificate or license. Timeframes for completing each step vary based on the type of product.
Conclusion
Regulatory compliance when selling, importing or manufacturing products under CDSCO is not simply a formality; rather, it is a legal requirement put in place to ensure the lives and health of the population throughout the country.
To be compliant with the law, companies must work diligently to obtain the necessary approvals so that they do not face substantial penalties (financially and criminally) for failing to comply with the laws governing these products (under the CDSCO).
Pharmaceuticals, medical devices, cosmetics, and other products regulated through the CDSCO should consider their regulatory compliance prior to entering the Indian market.
By obtaining the requisite approvals through the CDSCO, a business can be assured of protection, credibility, and long-term viability for that particular product.
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