Essential Medicines

1. India has adopted this concept from WHO. 
2. Essential medicines do not mean that they are only life saving drugs. 
3. In fact, the word life saving drugs is not defined in any of the domestic legislations.
4. These are the medicines that are required to be available with the health system all the time adequately.
5. When WHO published the 1st Model List of Essential Drugs in 1977, it identified 208 individual medicines which together could provide safe, effective treatment for majority of Communicable diseases and NCDs.
6. In India, National List of Essential medicines (NLEM) specified 348 drugs which formed the basis of DPCO.

Drug Prices and Control Order (DPCO), 2013

1. DPCO are issued under Section 3 of Essential Commodities Act, 1955. 
2. It gives powers to Govt to declare a ceiling price for essential and life saving medicines.
3. Price controls are applicable to "Scheduled drugs" i.e. those medicines which are listed in Schedule I of DPCO.
4. National List of Essential Medicines (NLEM), 2011 issued by MoHFW forms the basis Schedule I of DPCO.
5. Since 2013, all essential medicines (as defined under NLEM) are treated as Scheduled formulations (under DPCO 2013). It does not include any AYUSH medicine.
6. However, it does not mean that all drugs brough under price control are essential medicines.
7. Price controls are applicable irrespective of whether the drug is generic or branded.
8. National Pharma Pricing Policy (NPPP), 2012 is the policy governing price control and DPCO is the order by which price control is enforced.
9. Drug prices are monitory is monitored and controlled by National Pharma Pricing Authority (NPPA). All the powers of Govt relating to ECA are delegated to it.
   1. NPPA is an independent body of experts under Ministry of Chemicals and Fertilizers.
   2. It was formed in 1997 to implement and enforce provisions of DPCO for regulating prices of medicines.
   3. Functions:
      1. Fixing the prices of Scheduled drugs and Monitoring prices of decontrolled drugs.
      2. Monitor the availability of drugs, identify shortages, take remedial steps etc.
      3. Implement and enforce the provisions of DPCO.
10. It is important to note that Drugs and Cosmetics Act, 1940 under MoHFW do not contain provisions for pricing of drugs. Blood is a drug under Drugs and Cosmetics Act.
11. DPCOs are issued under Essential Commodities Act, 1955 by Ministry of Chemical and Fertilizers which is also the nodal agency for pharma companies. It now includes 376 medicines.
12. Under DPCO, 2013, the prices of 376 drugs have been brought under price control.
13. Generic medicine is the bioequivalent of the original drug, but cheaper.

The Central Drugs Standard Control Organisation (CDSCO)

1. CDSCO under Directorate General of Health Services, MoHFW is the National Regulatory Authority (NRA) of India.
2. Functions: Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice.
3. CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.