National Drug Policy/Generics Law

ROMEO R. ANDAYA, MD, MSCPD, PhD, FPAFP

Chair, DPMCH
UPH-DJGTMU
The National Drug Policy

Four Basic Components

1. Determinationof the need, scope & process
for policy formulation.
2. Conductof orderly & documented
consultations
3. Conduct of local research
4. Conduct of international research
The National Drug Policy
DOH conducted consultations from November
1986-March 1987 among the drug industry,
medical professional & consumer groups
which identified 7 issues.
1. A proposed essential drug list (EDL)
2. The use of generics vs brand names
3. Advertising & promotions
The National Drug Policy
DOH conducted consultations from November
1986-March 1987 among the drug industry,
medical professional & consumer groups
which identified 7 issues.
4. Procurement & self sufficiency
5. Self- medication
6. Basis for registration of pharmaceuticals
7. Pricing
NDP/Generics Law

On April 30, 1987, during the

inauguration of the BFAD
Laboratories in Alabang,
Muntinlupa, Pres. C. Aquino
announced the NDP & the
government’s commitment to its
implementation’
NDP/Generics Law

The Supreme Court has declared

the Generic Act of 1988 legal &
constitutional.

The Generics Act was signed into a

law on Sept 13, 1988 .
Implementing guidelines issued in
December 1988.
NDP/Generics Law

The DOH has conducted a sustained

information campaign about the law &
its provisions.

After more than 15 months, enough time

has been given to prepare for the law’s
implementation.
NDP/Generics Law

The responsibility to comply with the law

is now with the doctors, manufacturers,
drug stores & pharmacists.

The DOH will enforce the law & continue

to provide assistance & information to
the public.
Generics Law: RA 6675

Sec 1. Definition of terms

Sec 2. Guidelines on prescribing based
on previous laws
Sec 3. Additional guidelines on
prescribing to implement the Generics
Act oof 1988
Sec 4. Violative, Erroneous, &
Impossible Prescriptions
Generics Law: RA 6675

Sec 5. Violations on the part of

Dispensers & Outlets
Sec 6. Monitoring & Reporting of
Non-Compliance
Sec 7. Administrative Sanctions
Sec 8. Criminal Liabilities
Generics Law : RA 6675

Sec 2. Guidelines in Prescribing

• Only validly medical, dental & veterinary
practitioners are authorized to prescribe medicines

• All prescriptions must contain the name, office

address, PRC number, PTR number of the prescriber,
patient’s name, age , sex & date of prescription

• For prohibited drugs, needs , S2 license, DDB Rx

form, record system following DDB requirements
Sec 4. Violative Prescription

 Where generic name is not written

 Where the generic name is not legible
& brand name which is legible is
written
 Where the brand name is indicated &
instructions added ( such as ‘ no
substitution’ ) which tend to obstruct ,
hinder, or prevent proper generic
dispensing
Sec 4. Erroneous Prescription

 Where the brand name precedes the

generic name
 Wherethe generic name is the one in
parenthesis
 Wherethe brand name is not in the
parenthesis
 Where more than one product is
prescribed in one prescription form
Sec 4. Impossible Prescription

 When generic name is written & not

legible
 When the generic name does not
correspond to the brand name
 When both the brand & generic names
are not legible
 When one drug prescribed is not
registered with the BFAD