Good Manufacturing Practice (GMP) for Herbal Medicine
In India there are about 10 000 licenced pharmacies of ISM and herbal medicines
producing medicines [70]. With the increase in commercialization, some unscru-
pulous manufacturing practices have crept in to this profession, resulting in the
use of shortcuts to replace certain tedious and necessary processes, poor and inac-
curate labeling, and several other poor manufacturing practices. These have all ne-
cessitated the introduction of statutory Good Manufacturing Practices (GMPs) for
all ISM drug-manufacturing industries. The Government of India came up with
guidelines for the adoption of GMP standards by June 2002, and the details of the
provision of GMP for Ayurveda, Siddha, and Unani drugs are provided in the
Drugs and Cosmetics Amendment Rules, 2000. GMPs are prescribed to ensure
that: (1) raw materials used in the manufacturer of drugs are authentic, of pre-
scribed quality, and free from contamination; (2) manufacturing processes are as
has been prescribed to maintain the standards; (3) adequate quality control meas-
ures are adopted; and (4) manufactured drugs that are released for sale are of ac-
ceptable quality.
In addition to these guidelines, it is also required that at the factory in which the
medicines are prepared there must be adequate space for (a) receiving and storing
raw materials, (b) processing/manufacturing activities, (c) a quality control section,
(d) storage of finished goods, and (e) a proper office for record maintenance includ-
ing storage of rejected drugs/goods.
3.5
In India there are about 10 000 licenced pharmacies of ISM and herbal medicines
producing medicines [70]. With the increase in commercialization, some unscru-
pulous manufacturing practices have crept in to this profession, resulting in the
use of shortcuts to replace certain tedious and necessary processes, poor and inac-
curate labeling, and several other poor manufacturing practices. These have all ne-
cessitated the introduction of statutory Good Manufacturing Practices (GMPs) for
all ISM drug-manufacturing industries. The Government of India came up with
guidelines for the adoption of GMP standards by June 2002, and the details of the
provision of GMP for Ayurveda, Siddha, and Unani drugs are provided in the
Drugs and Cosmetics Amendment Rules, 2000. GMPs are prescribed to ensure
that: (1) raw materials used in the manufacturer of drugs are authentic, of pre-
scribed quality, and free from contamination; (2) manufacturing processes are as
has been prescribed to maintain the standards; (3) adequate quality control meas-
ures are adopted; and (4) manufactured drugs that are released for sale are of ac-
ceptable quality.
In addition to these guidelines, it is also required that at the factory in which the
medicines are prepared there must be adequate space for (a) receiving and storing
raw materials, (b) processing/manufacturing activities, (c) a quality control section,
(d) storage of finished goods, and (e) a proper office for record maintenance includ-
ing storage of rejected drugs/goods.
3.5
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