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The Union health ministry has notified an amendment to the Drugs Rules, 1945 to revise fees for various tests and analysis conducted by the Central and state drug laboratories, increasing the charges multifold, and fixing the fees of various other tests.
Now onwards, the cost of the test and analysis will automatically increase by 5% annually.
The new fee structure will be in force after three months from the date of publication of the notification.
A draft notification to substitute the existing Schedule B and B1 of the Drugs Rules, 1945, for a new fee structure was issued on January 22, 2026, inviting objections and suggestions from any person within a period of 30 days.
"... no objections or suggestions were received from the public on the said rules for consideration by the Central government," said the Ministry while issuing the final notification.
As reported earlier, the amendment has increased the fee for certain tests to almost 74 times higher than the prevailing fee.
According to the amendment, Schedule B will have three parts, with Part A for chemical drugs, Part B for testing of sera and vaccines, and Part C for tests related to homeopathic or herbal medicines and those of botanical, chemical or animal or microbiological origin. The Schedule B of the Drugs Rules, as updated till July, 2024, had a single part.
Schedule B(1), which stipulated the fees for the test or analysis by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) or the government analyst, lists 25 tests, while some of the tests earlier listed under this Schedule are now categorised under the Part C of Schedule B.
Under the amended Schedule B, fee for potency test for anti-snake venom serum to be increased around 74 times from Rs. 400 for each venom at present, to Rs. 30,000, while biochemical testing for the same will be Rs 7,500.
Determination of lethal dose, LD10 or LD50 in mice has witnessed a fee hike of almost 31 times to Rs. 25,000 compared to Rs. 800.
Testing of oral polio vaccine (OPV) had a fee of Rs. 400, and with the amendment, the fee for the test on potency or identity of OPV is Rs. 20,000.
Test fee for potency for tetanus vaccine and for potency testing of diphtheria following the implementation of the new Schedule will be at Rs. 45,000, each. The fee for potency testing of tetanus fraction of DPT/DT/TT vaccine based on the prevailing Schedule is Rs. 2,500 and potency testing for diphtheria fraction of DPT/DT vaccine is Rs. 2,700.
Fee for potency for pertussis component has been fixed at Rs. 36,000. Fee for potency testing of pertussis fraction of DPT vaccine as updated in 2024 is Rs. 2,025.
Fee for potency test for influenza vaccine, Rotavirus, J E Vaccine inactivated and live, potency/stability test of rabies vaccine, and NVT test in mice will have a fee of Rs. 20,000 each, while potency/stability/identity of measles component, rubella component, and mumps component will have a fee of Rs. 10,000 each.
Besides, for biochemical testing of inactivated polio vaccine, potency or stability testing of yellow fever vaccine, potency for tetanus antitoxin, stability for BCG vaccine, potency test for rabies monoclonal antibodies, total PRP for Hib component in tetravalent, pentavalent, and hexavalent vaccines, and free PRP for Hib component in these three vaccines, has been fixed at Rs. 10,000 each.
For tests not listed in the Schedule B, charges will be determined by the director or the government analyst of the laboratory or institute. Sample testing charges under the Schedule B(1) will be determined or revised by the Director, Pharmacopoeia Commission for Indian Medicine and Homoeopathy or Government Analyst of its Central Laboratory, in consultation with the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (Ayush).
The fees for test and analysis shall be those specified in Schedule B, according to the Rule 7 of the Drugs Rules, 1945. Under rule 48, the fees to be paid by a person submitting to the government analyst under Section 26 of the Act for test or analysis of a drug purchased by him shall be those specified in Schedule B.
The fees for the test and analysis of samples in Homoeopathy and other Ayush segments are specified in Schedule B-l, according to Rule 163F.
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