| 1.
|
Compliance
to Good Manufacturing Practice as recommended by
World Health Organization (WHO GMP) is the minimum
requirement for applying for registration. |
| |
| 2. |
Modern Medicine:
Manufacturers from USA, Canada, European Union,
Australia and New Zealand are registered if the
products are exported to any countries mentioned
in article 1 submission of registration dossiers. |
| |
| 3. |
Products of the
manufacturers from countries other than mentioned
in article 1 will be registered on submission of
registration dossiers. Products that are not exported
to those countries will not be considered for registration
at present. |
| |
| 4. |
UN prequalified vaccine
manufacturers (and prequalified vaccine) included
in Extended Programme on Immunization (DTP, Measles,
Tetanus Toxoid, Oral Polio, Hepatitis B, BCG) will
be registered on submission of registration dossiers. |
| |
| 5. |
Vaccine
other than mentioned in article 3, audit of the
factory from DDA is required. |
| |
| 6. |
Antiretrovirals,
Large Volume Parenterals, Anticancer drugs and contraceptives
and their manufacturers are registered if GMP compliance
status found satisfactory during audit from DDA. |
| |
| 7.
|
Herbal-based manufacturer
(Ayurvedic, Homeopathic, Unani etc) will be registered
if they have been awarded WHO GMP certificate and
if GMP compliance status is found satisfactory during
audit from DDA. |
| |
| 8. |
Application for registration
of industries producing other category of medicine
will be entertained at present. |
