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Drug Price Control Order 2013 – Facts About Drugs (Prices Control) Amendment Order, 2019

Ananya Gupta August 31, 2023 04:45 5253 0

DPCO full form is Drug Price Control Order. It is a regulatory framework issued under the Essential Commodities Act in India. DPCO empowers the government to control and regulate pharmaceutical product prices, ensuring accessibility and affordability of essential medicines.

Drug Price Control Order 2013 – Facts About Drugs (Prices Control) Amendment Order, 2019

Drug Price Control Order

The Drug Price Control Order (DPCO) is a regulatory framework implemented by various countries, including India, to control and regulate the prices of essential medicines. The primary objective of the DPCO is to make essential medications affordable and accessible to the general public, especially in countries where healthcare costs can be a significant burden on individuals and the healthcare system.

In the context of India, the DPCO is administered by the National Pharmaceutical Pricing Authority (NPPA), which is an organization under the Ministry of Chemicals and Fertilizers. The NPPA is responsible for regulating and controlling the prices of pharmaceutical products in order to ensure their availability at reasonable prices and to prevent the exploitation of consumers by pharmaceutical companies.

Under the DPCO, the government can regulate the prices of certain essential medicines by fixing their maximum selling prices. This is done to prevent pharmaceutical companies from charging exorbitant prices for critical drugs and to ensure that these drugs remain accessible to all sections of society. The list of drugs that fall under price control is generally determined based on their therapeutic importance and their impact on public health.

The DPCO framework may involve various methodologies for determining the prices of medicines, including cost-based pricing, market-based pricing, and more. It can also consider factors such as production costs, research and development expenses, and reasonable profit margins for pharmaceutical companies.

It’s worth noting that the specifics of the Drug Price Control Order can vary from country to country, and even within countries, the regulations might evolve over time. Therefore, if you are seeking information about the DPCO in a specific country or at a specific time, I recommend referring to the official government sources or regulatory bodies for the most accurate and up-to-date information.

DPCO Full Form

DPCO stands for Drug Price Control Order. The Drug Price Control Order (DPCO) is a regulatory framework implemented by governments to control and regulate the prices of pharmaceutical products, particularly essential medicines. The main goal of the DPCO is to ensure that essential medications are affordable and accessible to the general population, especially those who might otherwise face financial constraints in accessing necessary healthcare.

DPCO Full Form
Full Form Drug Price Control Order
Purpose Regulatory framework to control and regulate the prices of pharmaceutical products.
Legal Basis Issued under the Essential Commodities Act, 1955.
Objective Ensure affordability and accessibility of essential medicines.
Authority Ministry of Chemicals and Fertilizers, Government of India.

Why does Drug Price Control Order came into effect?

The Drug Price Control Order (DPCO) comes into effect primarily to address several important issues related to the pricing of pharmaceutical products, especially essential medicines. Some of the key reasons why the DPCO is implemented include:

  1. Affordability and Access to Medicines: Healthcare is a fundamental human right, and essential medicines are crucial for maintaining public health. The DPCO aims to ensure that essential medications are affordable and accessible to all segments of society, especially those with limited financial means. By regulating the prices of essential drugs, governments can prevent pharmaceutical companies from setting unreasonably high prices that could exclude many individuals from obtaining necessary treatments.
  2. Preventing Monopolistic Practices: In some cases, pharmaceutical companies might hold a monopoly over certain life-saving drugs, allowing them to charge exorbitant prices due to lack of competition. The DPCO prevents such monopolistic practices and price gouging, ensuring that companies cannot exploit the vulnerability of patients who rely on these medications.
  3. Balancing Innovation and Access: While pharmaceutical companies invest significant resources in research and development to create new drugs, there’s a need to strike a balance between encouraging innovation and making these innovations accessible to patients. The DPCO helps ensure that companies receive fair compensation for their efforts while still providing access to new and innovative treatments.
  4. Public Health Concerns: Access to affordable medicines is a critical aspect of public health. The inability to afford necessary medications can lead to worsened health outcomes and even loss of life. The DPCO’s purpose is to protect public health by making sure that essential medications are within reach of those who need them.
  5. Reducing Healthcare Costs: High healthcare costs, including the cost of medications, can put a strain on individuals and healthcare systems. By regulating drug prices, the DPCO can contribute to reducing the overall healthcare burden and improving the sustainability of healthcare systems.
  6. Social Equity: The DPCO aligns with the goal of achieving social equity in healthcare. It ensures that people from all economic backgrounds have equal access to essential treatments, regardless of their financial status.
  7. Preventing Price Inflation: In the absence of price controls, pharmaceutical companies might increase prices arbitrarily, leading to overall inflation in healthcare costs. The DPCO prevents this by setting reasonable price limits.

What is an Essential Medicine?

“Essential Medicines” refers to a curated list of medications that are deemed vital to addressing the healthcare needs of a population. This concept was introduced by the World Health Organization (WHO) in 1977, driven by the following crucial considerations:

  1. Public Health Relevance: Essential medicines are selected based on their significance in tackling prevalent health issues and diseases, thereby contributing to the overall health of a community.
  2. Evidence on Efficacy and Safety: Inclusion in the list requires concrete evidence of a medicine’s effectiveness and safety in treating specific conditions.
  3. Comparative Cost-Effectiveness: Essential medicines are evaluated for their cost-effectiveness, ensuring that the benefits they provide align with their affordability and value for money.

Features that define “Essential Medicines” include:

  • Continuous Availability: These medicines must be accessible at all times within functional healthcare systems, ensuring uninterrupted patient care.
  • Appropriate Dosage Forms: Essential medicines should be available in suitable dosage forms that cater to various patient needs and treatment methods.
  • Assured Quality and Information: These medicines should come with reliable quality assurance and adequate information for both healthcare professionals and patients.
  • Affordability: Essential medicines are introduced to the market with the aim of maintaining prices at levels that are affordable for individuals and communities alike.

The “Drug Price Control Order” (DPCO) underscores the need to streamline the usage of essential medicines. Governments can take several actions to achieve this goal:

  • Clinical Guidelines: Implementing clinical guidelines for pharmaceutical products, as seen in the DPCO, ensures that medicines are prescribed appropriately and in accordance with established standards.
  • Promotion of Drugs Committees: Establishing drugs committees at district and hospital levels can facilitate informed decision-making regarding medicine selection and usage.
  • Supervision, Audit, and Feedback: Regular oversight, audits, and feedback mechanisms help in monitoring and optimizing the utilization of essential medicines.
  • Public Education: Enhancing public awareness about medicines, their proper use, and potential risks contributes to responsible medication usage.
  • Adequate Government Spending: Governments must allocate sufficient resources to ensure a consistent supply of essential medicines and well-trained healthcare personnel.

Drug Price Control Order (DPCO) Amendments 2019 – Key Facts for IAS Exam

The DPCO Amendments of 2019 brought significant changes to India’s pharmaceutical pricing and regulation landscape. Introduced by: Ministry of Chemicals and Fertilizers. These key facts are essential for IAS exam preparation:

  1. Exemption for Innovative Patented Drugs: Drug makers introducing innovative patented drugs are granted exemption from price control regulations for a duration of five years from the date of marketing. This move encourages the development of novel pharmaceutical solutions.
  2. NITI Ayog Recommendation: The Department of Pharmaceuticals (DoP) implemented the amendments following recommendations from NITI Ayog, reflecting a collaborative approach between policy-making bodies.
  3. Exemption for Orphan Drugs: Drugs intended for treating rare or “orphan” diseases are also exempted from price control regulations. This exemption aims to boost the production of medications for diseases that affect a smaller patient population.
  4. Market-based Price Fixation: The central government retains the authority to fix drug prices based on market-driven data. This mechanism ensures that prices remain in line with prevailing market conditions.
  5. Source of Market-based Data: The market-based data used for price determination is sourced from pharmaceutical market data specializing companies as determined by the government. This data acts as a reference point for price calculations.
  6. Validation of Data: In cases where deemed necessary, the government has the option to validate the market-based data through appropriate surveys or evaluations. This step ensures accuracy and transparency in the pricing process.

Drug Price Control Order Act (DPCO Act)

The DPCO is issued under the provisions of the Essential Commodities Act, which gives the government the authority to regulate and control the prices of essential medicines and crucial bulk drugs that are important for public health. This regulatory framework allows the government to ensure that these medications are available to the public at reasonable prices and that pharmaceutical companies do not exploit consumers by charging excessively high prices.

The DPCO has a significant history, with its origins dating back to the 1970s when the government first introduced restrictions on the profits of pharmaceutical companies. This was a pivotal step in controlling healthcare costs and making essential medications more accessible to the general population.

The DPCO covers a range of aspects, including the process of fixing and revising drug prices, the procedures for implementation, the penalties and punishments for non-compliance, and more. It plays a crucial role in balancing the interests of the pharmaceutical industry with public health concerns, ensuring that vital medications remain affordable and available to all.

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Drug Price Control Order FAQs

The DPCO is a regulatory order issued by the Government of India under the Essential Commodities Act. It aims to control and regulate the prices of pharmaceutical products, especially essential medicines, to ensure their affordability and accessibility.

The primary purpose of the DPCO is to make essential medicines available to the public at reasonable prices, preventing the exploitation of consumers by pharmaceutical companies and promoting equitable healthcare access.

The DPCO is issued by the Ministry of Chemicals and Fertilizers, Government of India.

The DPCO empowers the government to set maximum allowable prices for specific pharmaceutical products. This prevents manufacturers from charging excessively high prices for essential medications.

The DPCO covers essential medicines, including bulk drugs and formulations. It may also include innovative patented drugs and orphan drugs.
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