6 Consequences of Non-Compliance During the Certification of Wholesale Drugs

Drugs like paracetamol, antacids, calcium, vitamin D3 supplements, and other anti-diabetics require strict lab testing. Before presenting these drugs in Indian markets, like hospitals, pharmacies, or other medical stores, they undergo rigorous lab testing. This process guarantees the standardization of medications to ensure safety and quality.

This process guarantees the standardization of medications to ensure safety and quality. At the same time, the business that sells the drugs in bulk quantities to hospitals, retailers, or other businesses also needs a valid license. It means that, for the wholesale drug license registration, you need to register with the relevant authority. 

However, if you are operating the wholesale drug business without a valid license, then you are in a serious legal risk trap. For non-compliance with drugs, a business can face serious legal penalties. In this comprehensive guide, we will explore which consequences arise with wholesale drug license non-compliance and how you can avoid them. Let’s read it in more detail.

What is Wholesale Drug Registration in India?

In India, registering your drug business with the regulatory authority marks the legal formality. If you are a wholesaler of pharmaceuticals conducting business throughout India, it is essential to obtain a drug certificate. The Central Drugs Standard Control Organization serves as the regulatory body overseeing pharmaceuticals.

This governing authority operates a complete process of drug approval, from the approval of new drugs to post-compliance review. In addition, the business that distributes drugs in bulk to retailers, hospitals, or other businesses requires a pharmacy license to apply online. Within the legal boundaries, the wholesalers are allowed to operate the business. Moreover, the wholesale drug license registration certificate is issued by the State Licensing Authority, which is DCGI, the head of CDSCO.

What are the Penalties for Non-Compliance?

The Indian government continuously oversees the operations of the pharma industry to safeguard patient health. Moreover, the newly established rules and regulations are also enforced to limit the access of fraudsters. On the other hand, if a wholesaler is operating the drug business without a pharmacy license, then it will be marked as an illegal operation. It signifies that non-compliance with wholesale drug license registration in India can result in severe consequences. These consequences can be potential fines, imprisonment, or a block from market entry, even license revocation. The penalties can be stricter if a drug is deemed spurious or likely to harm a patient.

Here are the details of which penalties that can arise with drug non-compliance:

1. Fines: The non-compliance with the wholesale drug license, a business can face serious fines. The monetary penalties include the fines that are imposed for non-compliance. In rough, the fine can be made against the wholesale drug business minimum of Rs 5000. However, if the violation is higher, the fine penalty can be significantly increased. Mostly, the fines are imposed against businesses for spurious or harmful drugs. 
2. Imprisonment: The serious violation related to drugs can lead to a wholesaler to a minimum of one year imprisonment. But it can be increased to three or even higher if the violation is more harmful or in case of a patient’s death. 
3. License Revocation: The repetition of a violation or action can cause the drug safety certification revocation. It means your license will be permanently seized, and you will not get a chance to work in the Indian pharmaceutical markets. Even your business will permanently shut down.
4. Legal Action: If your wholesale drug business is responsible for an individual’s harm, in this case, criminal legal action will be taken against you. 
5. Business reputation damage: The non-compliance significantly affects the business reputation. The damage to business reputation leads to financial losses, loss of trusted customers, and disruption of operations. 
6. Impact on Public Health: Non-compliance can significantly impact the health of patients. The unregistered causes potential reactions in patients. 

User Query: Top Reasons Why Drug Licence Applications Are Rejected?

How to Avoid Non-compliance to Prevent Penalties?

Meeting the regulatory authority requirements is the best option to protect your wholesale drug business from potential penalties. To avoid non-compliance, you need to comply with legal compliances, keep maintaining records, get valid licenses, update facilities, and renew the certificate promptly. The key areas to focus on are

Storage and Handling

• To store the drug, the unit must have the proper storage facilities, including options for humidity and temperature control.
• It is imperative to have an appropriate strategy for the disposal or management of expired medications. Additionally, it is essential to have storage facilities for medications that are sensitive to temperature.

Record Keeping

• The staff or the wholesaler is required to maintain complete records of all drug purchases and sales.
• Properly secure the drug sample testing records or any other information that can accurately signify drug quality.

Staff Training

• Provide the training or conduct the session for the staff so that they can understand why the quality of the drug matters. 
• The designated wholesale drug business employees must have a degree in retail operations.

Licensing and Renewal

• For the drug license in India, register with the Central Licensing Authority. It is compulsory to display the drug license number on pharmaceutical product packages.
• Apply for the drug license renewal before its expiry. Also, stay updated with regulatory guidance changes to meet authority needs. 

Final Words | Wholesale Drug License Registration

In Indian markets, drug business operators are only allowed if they have a proper license. A wholesale drug license is required when a business distributes the drugs in bulk. Through the drug license online application procedure, you are complying with Indian standards. Apply now for the wholesale drug license in India to protect your business from legal risks like fines, imprisonment, or potential criminal charges. 

FAQ | Drug Safety Certification in India 

1. Who is responsible for GMP compliance?

Ans. The standardization of pharmaceuticals is monitored by the Food and Drug Administration (FDA). It further monitors the Good Manufacturing Practice (GMP) regulations. 

2. What is NSQ in the pharmaceutical industry?

Ans. In the pharma sector, the word “NSQ” refers to “Not of Standard Quality.” It specified those drugs that failed the CDSCO-specific Indian Standard requirements. 

3. Who approves the new drugs in India?

Ans. The Drugs Controller General of India (DCGI) conducts the clinical trials and grants approval for new drugs.

4. Which form is required for a wholesale drug license for allopathic?

Ans. For the allopathic, the wholesaler is required to fulfill Form 20B and Form 21B. 

5. What is the cost of a wholesale drug license in Delhi?

Ans. To obtain the certificate for your wholesale drug business in Delhi, you need to pay a minimum of Rs 39,999.