The First, Second and Third Schedule

THE FIRST SCHEDULE

It consists of the list of bulk drugs, around 74 used in the treatment of different ailments. The drugs include-sulphamethoxazole, penicillins, tetracycline, analgin, doxycycline, ciprofloxacin, rifampicin, cefotaxine, streptomycin, ranitidine, dexamethasone, ephedrine, vitamins A, B 1, B2, C & E, betamethasone, carbamazepine, metronidazole, chloroquine, theophylline, insulin, erythromycin, levo-dopa, tolnaftate, oxytetracycline, nalidixic acid, prednisolone, griseofulvin, cephazolin, gentamycin, methyl dopa, aspirin, halogenated hydroxyquinoline, dextropropoxyphene, trimethoprim, cloxacillin, pentazocine, sulphadimidine, captopril, salbutamol, naproxen, pyrental, sulphadoxine, famotidine, ibuprofen, norfloxacin, frusemide, cafadroxyl, pheniramine maleate, panthenols and panthonates, chloroxylenols, furazolidone, becampicillin, pyrithioxine, lincomycin, chlorpropamide, sulphadiazine, framycetin, mebhydroline, chlorpromazine, verapamil, methendienone, phenylbutazone, glipizide, Iynestranol, spironolactone, salazosulphapyrine, pentoxyfYlline, diosmine, amodiaquin, trimipramine, and sulphamoxole

THE SECOND SCHEDULE

It consists of different forms to be submitted such as, (i) Form of information/application for fixation or revision of prices of Scheduled bulk drugs (in duplicate), (ii) Form of information in respect of price of non-scheduled bulk drugs (in duplicate), (iii) Form of application for approval or revision of price of Scheduled formulations (seven copies), (iv) Form of application for approval or revision of price of Scheduled formulations imported in finished form (seven copies), (v) Form of Price List and (vi) Yearly information on turnover and allocation of sales and expenses.

THE THIRD SCHEDULE

It specifies maximum pre-tax return on sales turnover of manufacturers or importers of different formulations. There are three categories of units for this purpose.

(i) Category A : Units with turnover of more than 6 crores per annum

(ii) Category B : Units with turnover between Rs. 1 crore to Rs.6 crores per annum

(iii) Category C : Units with turnover of less than 1 crore per annum.

The Central Government has the power to fix maximum sale price of indeginously manufactured bulk drugs specified in First schedule. While fixing the price of a bulk drug, the Government takes into consideration a post tax return of 14% or a return of22% on capital employed or in respect of a new plant an internal rate of return of 12%. Where the production is from basic stage, the Government shall take into consideration post-tax return of 18% on net worth or a return of26% on capital employed.

Time Limits:

Fifteen days time for new bulk drug (First Schedule) production by the manufacturer, as well as, for implementation of policy matters announced by the Government. An application for revision of maximum sale price of bulk drug in Form I submitted by the manufacturer, shall be responded by the Government after careful study within four months from the date of receipt of complete information.

Every manufacturer shall furnish within thirty days of commencement of this order a list of all Scheduled drugs produced by him to the Government in Form I and that of non-scheduled drugs in Form II.

Both for bulk drugs and formulations, the manufacturer is required to submit the price list every year within one month of introduction of annual Finance Bill to the Government.

The Government may direct any manufacturer of any bulk drug to sell such drug to other manufacturers of formulations in order to ensure adequate and equitable distribution. The Central Government has to look into the requirements for captive consumption of such manufacturer and also to think of plant growth of pharmaceutical industry.