Reform of India’s drug regulatory framework.
Drug Regulation in India:
India is one of the largest manufacturers of drugs and exports pharmaceutical products to over 200 countries/economies.As India has a federal form of government, so the medical regulatory structure is divided between national and state authorities.
Medicines in India are regulated by CDSCO – Central Drugs Standard Control Organization under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through DCGI – Drugs Controller General of India at Chair.
Functions of CDSCO:
- Approval of new drugs and clinical trials
- Import Registration and Licensing
- Licensing of Blood Banks, LVP’s, Vaccines, r-DNA products & some Medical Devices
- Amendment to D &C Act and Rules
- Banning of drugs and cosmetics
- Grant of Test License,
- Personal License,
- NOCs for Export
- Testing of Drugs
The term ‘pharmaceuticals regulation’ means the regulation of any aspect of the production, distribution, prescription or consumption of a pharmaceutical product or the raw materials that are used in its production.
Major Issues in Indian Regulatory System:
- The regulation of pharmaceutical products in India with apparently strong regulations but weak Implementation – is not a unique situation.
- At the level of the consumer there is self – prescription of the drugs, with or without written prescription.
- Issued are observed in the license system which is needed to manufacturing, sale or distribution of the pharmaceutical products in the country.
- Medicines cannot be introduced in the Indian market without the permission of DCGI of India, but the manufacturing license is provided by the State Licensing Authority.
- The processes of removing dangerous or inefficacious medicines are very hard to implement, so it become quite hard to follow the circumstances.
- As there is an act regarding the price of pharmaceutical products but practically the implementation of this act is very poor.
- India is also listed by the Pharmaceuticals Security Institute [PSI] as one of the top five sources of counterfeit drugs about 20% of medicines in the country are fake or sub-standard.
- Lack of regulatory expertise and testing facilities which are required to implement standards.
- Lack of clarity on patentability and conditions of pharmaceutical substances under which firms can apply for compulsory licenses which can prevent legal battles between local firms, MNCs and civil rights groups.
- Lack of coordination, accountability and transparency in functioning among different ministries concerned with drug regulation.
Most worrisome issue
- The most worrisome issue is that India does the mandatory basic quality testing services for medicines which are meant for exports because countries like the U.S will not accept any drug formulation which is not proven bioequivalent.
- But, when several Expert Committees recommended bioequivalence studies for all generic drugs, it was rejected by the Drug Consultative Committee (DCC) rejected it on the grounds that India lack the infrastructure.!!
- On top of that, European countries are selling medicines in India that are not approved in their home countries, or, for that matter, in any developed country.
The Pharmaceutical industry is politically very powerful and it has used all its influence in the past to block reforms initiated by the Government.
Effect of poor drug regulations
- Substandard medicines are causing negative health outcomes.
- Increased antibiotic resistance has been recorded in the past few years.
- It is a waste of public money, as there is failure to cure diseases.
- The long-term effects will be devastating to public health, especially to the poor and vulnerable.
Recent steps taken by the Government to Strengthen and Upgrade our drug regulatory system
- Provision of additional equipment and manpower in existing drug testing laboratories.
- Setting up of new laboratories for testing drugs, medical devices and cosmetics.
- Making mobile drug testing laboratories available
- Creation of additional manpower for regulatory structures.
- Introduction of organisation wide e-Governance and Information Technology enabled/ online services.
- Setting up a training academy for both the Central and State regulatory and drug testing officials.
- Assistance to the States for strengthening their drug regulatory structures.
What else can be done?
We need to make centralised licensing because States lack the necessary resources to coordinate their activities among themselves, and this loophole is exploited by the manufacturers.