On November 3, 2017, the Central Government proposing to make changes or amending the Drugs and Cosmetics Rules, 1945 in exercise of the powers conferred by sections of the Drugs and Cosmetics Act, 1940 (23 of 1940), in further consultation with the Drugs Technical Advisory Board (DTAB), has issued three separate drafts to the public, which will be taken into consideration on or after the expiry of a period of thirty days from the date of publication. The details are:

1. In the first draft Notification (S.O. G.S.R.1367 (E)), the government has proposed to substitute the existing clause 3 of Form 12B of the Drug and Cosmetic (D&C) Rule, 1945 with respect to permission of import of small quantities of drugs for personal use - allowing it till the patient requires the drug as per prescription of RMP as against the present restriction of six months from the date of issue of the permit. However, it is also proposed that the permit holder should submit the details of the drugs imported and utilized, to the licensing authorities on a yearly basis from the date specified17.

2. In the second draft Notification (S.O. G.S.R.1368 (E), the government proposes to substitute serial number 34 under Schedule K of the D&C Rule, 1945 by including "production of Oxygen 93 percent IP in addition to Oxygen 93 percent USP for exemption of the provision of the Chapter IV of the Act. The Provision of Chapter IV of the Act and the Rule made thereunder, which requires them to be covered by manufacturing license under the rules, provided that the production facilities shall be open to inspections by an inspector appointed under the Act, who can, if necessary, take samples for test18"

3. In the third draft rule, the following amendments are sought vide Notification No. G.S.R.1369 (E), -

  • It is proposed to substitute the clauses in Rule 96, in sub-rule (1), in clause (xi) D&C Rule, 1945 "In addition to the other particulars which are required to be printed or written under these rules, the label of inner most container of the following categories of drugs and every other covering in which the container is packed shall bear caution/ warning in legible black colored font size in completely red rectangular box without disturbing other conditions printed on the label under these rules, namely:- Narcotic analgesics, hypnotics, sedatives, tranquillizers, corticosteroids, hormones, hypoglycemic, antimicrobials, antiepilep- tic, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under Schedules G, H, H1 and Schedule X whether covered or not in the above list".
  • In clause (a), (b), (c), (d) and (e) of sub-rule (1) of Rule 97 of D&C Rules, 1945 indicating the manner of labeling of drugs specified in Schedule G, H, H1, and X shall be "in red and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black colored font size in completely red rectangular box".
  • In Schedule H, after Note 3 appended to the said Schedule, the following Note shall be inserted "The salts, esters, derivatives and preparations containing steroids for topical or external use are also covered by this Schedule."
  • In Schedule K, against serial number 27, for the entries under the column 'class of drugs' the following shall be substituted "Oral Rehydration Salts (Manufactured as per the following formula):-Composition of the formulation in terms of the amount in gm, to be dissolved in sufficient water to produce 1000 ml.

Sodium Chloride 2.6

Dextrose (anhydrous) or 13.5

Dextrose mono-hydrate 14.85

Potassium Chloride 1.5

Sodium Citrate 2.919."

Note - The Health Ministry hereby requests that objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare. Objections and suggestions which may be received from any person within the aforesaid period will be considered by the Central Government.

Footnotes

17 http://egazette.nic.in/WriteReadData/2017/180036.pdf

18 http://egazette.nic.in/WriteReadData/2017/180051.pdf

19 http://egazette.nic.in/WriteReadData/2017/180071.pdf

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