The document discusses India's national drug policies from 1978 onwards. It provides details on the key features of the 1986 drug policy and the modifications made in the 1994 drug policy. Some of the major changes in the 1994 policy included removing restrictions on industrial licensing approvals, abolishing the supply of bulk drugs only to associated formulators, treating companies with 51% equity as Indian companies to encourage foreign investment, and establishing the National Pharmaceutical Pricing Authority to regulate drug prices. The 1994 policy aimed to promote self-sufficiency, affordable access, and encourage the indigenous pharmaceutical industry in India.

1. BY
LAYATMIKA
NAYAK
MPHARM 1ST YEAR
NEW DRUG POLICY 1994

2. WHAT IS A DRUG POLICY ?
•A DRUG POLICY BECOMES A GOAL GUIDE OR
ACTION .IT EXPRESSES MEDIUM TO LONGTERM
GOALS SET BY THE GOVT. FOR PHARMACEUTICAL
SECTOR.
•FRAMEWORK TO COORDINATE ALL THE
ACTIVITIES OF THE PHARMACEUTICAL SECTOR.
•COVERS BOTH THE PUBLIC AND THE PRIVATE
SECTOR.
•WHO RECOMMENDS THAT A COUNTRY SHOULD
POSSESS AND FORMULATE A COMPHREHENSIVE
NATIONAL DRUG POLICY.

3. •PRESENTED AND PRINTED AS AN
OFFICIAL
STATEMENT.
THE IDEA OF DRUG POLICY
WAS IMPLEMENTED BY THE
HATHI COMMITTEE for the first
time.

4. FOCUSED ON POINTS LIKE
•SELFSUFFICIENCY IN MEDICINES
•ABUDANT AVAILABILITY AT REASONABLE
PRICES OF ALL ESSENTIAL DRUGS.
•INDIGENOUS ENCOURAGEMENT
SELFSUSTAINING OF PHARMACEUTICAL
SECTOR IN OUR COUNTRY.

5. IT GAVE WAY TO GROW THE
PHARMACEUTICAL INDUSTRY IN ENTIRE
THIRD WORLD.
FIRST NATIONAL DRUG
POLICY WAS DECLARED IN
1978 AND THEN IT WAS
REVISED IN 1986,1994 AND
2002.

6. SALIENT FEATURES OF 1986 DRUG POLICY
ENSURE ABUDANT AVAILIABILITY AT
REASONABLE PRICES OF
ESSENTIAL,LIFESAVING AND
PROPHYLACTIC MEDICINES OF GOOD
QUALITY.
STRENGTHEN THE QUALITY OF DRUG
PRODUCTION AND PROMOTION OF
RATIONAL USE OF DRUGS IN THE
COUNTRY
CREATING AN ENVIRONMENT FOR NEW
INVESTMENT TO THE PHARMACEUTICAL
INDUSTRY.
COST EFFECTIVE PRODUCTION
INTRODUCING NEW TECHNOLOGY AND

7. FOCUSING ON INDIGENOUS PRODUCTION OF
DRUGS.
SUGGESTION TO CREATE A NATIONAL
DRUG AND PHARMACEUTICAL
AUTHORITY AS A ADVISORY BODY.
TO ENCOURAGE GMP AND TO GIVE GMP
CERTIFICATE TO FORMULATOR INSTITUTIONS
WHO HAVE PROVEN EXPERTISE AND TESTING
FACILITIES.
REVISE AND ISSUE OF A DRUG PRICE
CONTROL ORDER.
ENCOURAGE RESEARCH AND USE OF
GENERIC NAME.

8. NEW DRUG POLICY 1994
MODIFICATIONS OF
 EXIM POLICY i.e EXPORT IMPORT
POLICY
DUE TO GATT i.e GENERAL AGREEMENT
ON TARIFFS AND TRADE
WTO i.e WORLD TRADE ORGANIZATION

9. SALIENT FEATURES OF NDP
1994
1.INDUSTRIAL LICENCING
NO MORE RESTRICTIONS TO THE
APPROVAL WHEN IT ATTAINS TWO MORE
CONCEPTS i.e basic stage manufacture is
satisfactory and discouraging undue imports.
Further many drugs reserved for public
sector undertaking have lost relevance on
regards to the above points hence list of
items reserved for PSU was done e.g Vitamin
B1 ,FOLIC ACID,TETRACYCLINE
,OXYTETRACYCLINE etc.

10. IT WAS RENEWED EVERY THREE YEARS.
INDUSTRIAL LICENCE FOR ALL BULK DRUGS
WAS CLEARED BY DRUG CONTROLLER OF
INDIA.
EXCEPT (i) BULK DRUGS FOR PSU
• (ii) BULK DRUGS PRODUCED BY
RECOMBINANT DNA TECHNOLOGY AND
NUCLEIC ACIDS AS THE ACTIVE PRINCIPLE.
ABOLISHMENT OF SUPPLY OF BULK DRUGS
PRODUCTIONS TO NON ASSOCIATED
FORMULATORS
LIMITING THE USE OF IMPORTED PRODUCTS.
GRANT OF COB LICENCE i.e Carry On Business
Licence ACCORDANCE TO NORMS AND

11. R AND D
THRUST AREA FOR EXPORT & IT SHOULD BE COST
EFFECTIVE
IMPENDING CHANGES IN THE PATENT LAW IN VIEW
OF GATT i.e GENERAL AGREEMENT OF TARIFFS AND
TRADE.
EVEN NEW DRUG WHICH IS INDIGENOUS IS PUT
OUTSIDE OF PRICE CONTROL FOR A PERIOD OF 10
YEARS FROM THE DATE OF COMMERCIAL
PRODUCTION.
QUICK EVALUATION AND CLEARANCE BY THE
CONCERNED IS NECESSARY TO ENCOURAGE
INDIGENOUS RESEARCH WORK.

12. INVESTMENT
PRIMARY NEED TO ACHIEVE FUTURE DEMANDS
PHARMACEUTICAL SECTOR SHOULD BE TERMED AS
A HIGH PRIORITY AND USED FOE FOREIGN
INVESTMENT
IN TERMS OF NEW INDUSTRIAL POLICY
•PROPOSED TO TREAT COMPAINES WITH 51% EQUITY
ON PAR WITH INDIAN COMPANIES
•AT PRESENT 40% ARE ALREADY ENJOYING THIS
FACILITY

13. PRICING
•IMPLEMENTED BY NATIONAL PHARMACEUTICAL
PRICING AUTHORITY TO DO WORK ON PRICE FIXATION.
•PRICE FIXATION IS DONE EACH YEAR
•MONITOR THE PRICE OF DECONTROLLED DRUGS AND
FORMULATIONS
•GUIDE THE IMPLEMENTATION OF DRUG PRICES
CONTROL ORDER

14. DRUGS WERE CATEGORIZED INTO TWO LISTS
MAXIMUM ALLOWABLE POST
MANUFACTURING EXPENSES(MAPE)
•LOWER MAPE OF 75% ARE DONE FOR
THE DRUGS UNDER NATIONAL HEALTH
PROGRAM
•100% FOR OTHERS CATEGORY II DRUGS.

15. CONCLUSION
•SHOULDNOT BE STATIC AND SHOULD
CHANGE according to the need of time.

16. THANK YOU