Drug Price Control Order Act (DPCO Act)

Drug Price Control Order Act (DPCO Act) -  The Drug Price Control Order Act (DPCO Act) is under the Essential Commodities Act. This act helps in controlling the pricing of pharma medicines. In this blog, we are discussing the Drug Price Control Order Act and its objectives, and importance. Also, covering the documents required for obtaining a drug license and all the related topics.

The govt. Adopt a primary list of essential drugs called the National List of Essential Medicines. As per the data, currently, there are 680 drugs formulations under 27 therapeutic groups. This govt. Policies help in preventing monopolies from being formed by the pharma companies in the market. Also, it makes sure that all patients get the basic healthcare facility by providing affordable and quality drugs in the Indian market. 

For any pharma business, there are some rules and regulations that need to be followed. If you are interested in starting your own business in pharma, then this blog will help in finding all the information. However, there is a drug license that gives you permission of selling or manufacture pharma ranges. However, there are several kinds of drug licenses and you can apply for them as per your requirement. Like - Drug manufacturing, Wholesale, retail, import, other medical supplies, etc.

The Drug Price Control Order Act and Its Objectives

The Drug Price Control Order, 1995 is under the section of the Essential Commodities Act, 1955. According to this act, there will be proper price control of medicines and fixation of essential drugs. Also, this act covers the implementation of this price list of essential drugs. Moreover, there are some main objectives of this Drug Policy, such as 

  1. Ensure the proper supply of all the essential drugs.
  2. Make sure that these drugs are comes in an affordable range
  3. Assuring the quality standards of all the medicines comes under this essential category.
  4. Strengthen the quality control in the country.
  5. Creating new investment opportunities in the country.
  6. Making the production process cost-effective by introducing new technology

What is the importance of the DPCO Act?

First of all, let’s discuss essential medicine. The word “essential medicine” came into existence in the year 1977 by WHO (World Health Organization). This category of medicine consists of all the necessary medicine a human will require for basic healthcare facilities. Also, there are factors that make medicine into the essential medicine category, such as public health, cost-effectiveness, and effectiveness. 

  • To make sure that these medicines under the essential category should be available in the market in abundance. 
  • To prevent companies from controlling the demanding drugs in the market.
  • Providing the best quality and affordable medicines under this category.
  • This help in providing basic healthcare facility to the large population. 
  • Moreover, the government followed an extensive process for implementing this essential medicine list, such as 
  • Proper conducting of the clinical guidelines and drug committees to be set up in all the hospitals. Also, supervising, auditing and providing feedback to these committees. 
  • Make sure that there must be enough stock for these drugs. 

About National Pharmaceutical Pricing Authority (NPPA) 

The National Pharmaceutical Pricing Authority came into existence in the year 1997. The main role of this authority is to revise the pricing list of bulk drugs and formulations and to enforce the Drugs Price Control Order. Also, monitored the essential drug list. Also, Those drugs that came under the non-scheduled drug list are not required for pricing approval from the NPPA. This authority only measures the drugs under the scheduled list. Generally, the margin is fixed at 16%.

Following is the list of functions of NPPA

  1. Implementation and Enforcement of Drug Price Control Order.
  2. Sponsoring studies of related fields.
  3. Monitoring the stock of drugs
  4. Maintaining production, import and export, etc of companies
  5. Deal with the legal matters
  6. Revision of the drug policy
  7. Assisting the central for drug pricing.

Essential Information Need To be Mention On the Printed Label Of Medicines

As per the act of Drugs & Cosmetics Act & DPCO, there is mandatory of mentioning the following information on the printing label of all drugs under the scheduled list, otherwise there will be serious penalty to the manufacturer or the company  - 

  1. Formulation & Composition of the drug
  2. Size or quantity
  3. Address of the manufacturer
  4. Manufacturing license number
  5. Date of manufacture
  6.  Expiry date 
  7. MRP


For any country, Healthcare is a vital part. The govt. Make sure that each citizen gets basic healthcare benefits at a minimal cost. That’s why the govt. Came with this kind of act and rules & regulations. At last, we are hoping that you get all the information regarding Drug Price Control Act. However, if you still have any doubt, then feel free to reach out to Bendic Healthcare!

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