Upgraded Good Manufacturing Practices (GMP) certificate and minimum turnover may be made two key pre-conditions among other specific norms for the manufacturers to participate in tenders to supply drugs to the Government in near future.
As followed by Maharashtra and Tamil Nadu governments, the Central government has also been urged to set norms as pre-conditions for submitting tenders by the companies when Government goes for bulk purchases. Preference is also likely to be given to generic drugs.
A centralized purchase system for drugs in all central organizations and states in the larger public interest and releasing of all pre-conditions for the benefit of the public are also being mooted to streamline the often criticism-marred drug purchasing deals.
The proposals, which can curb the flaks and controversies on drug purchases, have been included in the draft recommendations submitted by the Working on Drugs and Pharmaceuticals for the eleventh Five Year Plan.
If the proposals get through, a third party quality assurance, as being done by the Health Department for World Bank funded drugs, may also come in place to put that agency fully responsible for the quality of medicines.
Technical and price bids should be invited in separate envelops. Bids/tenders are invited through press and website of the concerned department. Procurement could be made only from pre-qualified manufacturers, the panel said.
``Schedule M for GMP compliance of the manufacturer should be ensured. In case of Ayurveda, Siddha and Unani drugs, schedule T must be made mandatory and quality should be assessed as per guidelines of research councils,'' the report suggested.
Minimum three years of track record in sustained production and marketing of the concerned drug, balance sheets for three years, assessing of financial capacities and post-tender award inspection are some of the other guiding factors recommended.
"Batch-wise sample testing of drugs from the government-run or government-approved laboratories be made before putting them into use and penalties, including debarring from future bids, must be imposed on the defaulters,'' the report said.
Packaging specifications for better shelf life, a minimum shelf life of two years, avoiding of local purchase and destruction of expired drugs by the hospitals were also among the suggestions.
``In case the price quoted by a manufacturer is lower than the price fixed by NPPA by more than 35 percentage points, he may be asked to provide justification for the same. If he fails to do so, his may be rejected,'' the report said.
Besides consumer awareness campaigns through the media about the precautions like avoiding purchase without cash memo, the panel also suggested a dedicated website to pass information about the matters to the public.