Central Drugs Standard Control Organization (CDSCO), in coordination with concerned State Licensing Authority for action as per the provisions of Drugs & Cosmetics Act, 1940 (the 'Act'), and the Drugs & Cosmetics Rules, 1945 (the 'Rules'), has taken various measures by way of bringing about certain amendments in the existing regulations, to ensure the quality of drugs including generic drugs manufactured / marketed in the country. In the year 2018, there were a total of ten amendments in the Rules. The brief details of amendments are as under:
1. Printing Drug's Generic Names in Bigger, Bolder Font than Brand Name
On March 13, 2018, the Drugs and Cosmetics (First Amendment) Rules, 2018 notified under Gazette notification no. G.S.R. 222 (E) amended Rule 96 of the Rules. The amended rule now provides that the proper name of the drugs (generic) shall be printed in a conspicuous manner which shall be in the same font but at least two font size larger than the brand name or the trade name, if any1. According to the Drugs and Cosmetics (Eighth Amendment) Rules, 2018, the labelling requirement shall be on a voluntary basis for a period from 13.09.2018 to 31.03.2019 and thereafter shall be mandatory2.
2. Steroidal drugs are included under Schedule H of Drugs and Cosmetics Act, 1940
Vide Gazette notification no. G.S.R. 277(E) dated March 23, 2018 the Drugs and Cosmetics (Second Amendment) Rules, 2018 were notified thereby updating Schedule H provided under the Rules, with addition of 14 Steroidal drugs - Alclometasone, Beclomethasone, Betamethasone, Desonide, Desoximetasone, Dexamethasone, Diflorasone diacetate, Fluocinonide, Fluocinolone acetonide, Halobetasol propionate, Halometasone, Methylprednisone, Prednicarbate, and Triamcinolone acetonide - making them prescription drugs for patient use3.
3. CDSCO mandates the submission of stability data of all drugs before granting product license
On April 10, 2018, the Drugs and Cosmetics (Third Amendment) Rules were notified vide Gazette notification no. G.S.R. 360 (E), 2018, for replacing the words 'patent or proprietary medicines' with the word ' drugs' of rules 71, 71b, 76, 76A, and schedule D of the Rules; which now makes it mandatory to submit stability data etc. for all drugs by applicant as per the provision before grant of product license by the respective State Licensing Authority4.
4. Inclusion of Oxygen 93% supplied from liquid oxygen for production of Oxygen 93% USP under Schedule K
Vide Gazette notification no. G.S.R. 385(E) dated April 19, 2018, the Drugs and Cosmetics (Fourth Amendment) Rules, 2018, amended the Rules, and thereby included under Schedule K, Oxygen 93% supplied from liquid oxygen in the production of Oxygen 93% USP by a hospital or medical institute for their captive consumption, in addition to oxygen being produced from air by the molecular sieve process. Making it under Schedule K provides exemption from the applicability of provisions of Chapter IV (Manufacture, Sale and Distribution of Drugs and Cosmetics) of the Act, and the rules provided that the production facilities shall be open to inspections by an Inspector appointed under the said Act5.
5. Central Government notify labeling specification of Schedules G, H, H1 and Schedule X drugs
On April 26, 2018, the Drugs and Cosmetics (Fifth Amendment) Rules, 2018 notified vide Gazette notification no. G.S.R. 408(E), updated the labeling specification of inner most container of the following categories of drugs and every other covering in which the container is packed shall bear a caution or warning, as applicable, depending on whether the drug is covered under Schedule G or Schedule H or Schedule H1 or Schedule X, as specified in Rule 97, in legible black coloured font size in a completely red rectangular box without disturbing other conditions printed on the label under these rules.
The labelling specification applies on narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemic, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under Schedules G, H, H1 and Schedule X whether covered or not in the said schedules6.
6. Extended validity of Drug import license for personal use
On June 01, 2018, the Drugs and Cosmetics (Sixth Amendment) Rules, 2018 notified vide Gazette notification no. G.S.R. 521(E) updated Form 12B, which now allows permit holder to import the medication for personal use till such time as the patient requires the drug as per the prescription of a registered medical practitioner, and the permit holder shall submit details of drugs imported and utilized to the licensing authority on yearly basis, which was for only six month period earlier7.
7. Oxytocin reclassified as Schedule H1
Vide Gazette notification no. G.S.R. 795(E) dated August 21, 2018, the Drugs and Cosmetics (Seventh Amendment) Rules, 2018 reclassified oxytocin from the list of Schedule H drugs to Schedule H1 drug under the Rules, which requires retail chemists to document the customer and physician details for each sale for at least 3 years further to check the indiscriminate use of drug8.
Moreover, the Central Government also announced the strict regulatory control over manufacture, sale and distribution of oxytocin this year to curb its misuse under section 26A of the Act.
8. Clarification in case of use of colors in empty gelatin capsules (Hard and Soft)
On December 07, 2018, the Drugs and Cosmetics (Ninth Amendment) Rules, 2018 notified vide Gazette notification no. G.S.R. 1186(E) amended Rule 127, that in the manufacture of gelatine capsule approved/permitted colours shall be used and drug label containing gelatine capsules need not indicate the name of colour added as more than one colours are quite often used9.
9. Revised regulatory fees for various drug licensing activities
On December 12, 2018, the Drugs and Cosmetics (Tenth Amendment) Rules, 2018 notified vide Gazette notification no. G.S.R. 1193(E) revised regulatory fee and increased the fee for site registration, product approval, licenses for import of drugs and medical devices, permissions for clinical trials and import of drugs for tests and overseas inspections10. Notable, the Central government last updated this fee in 2003.
10. Mandatory unique ID number system to keep a check on misleading advertisement for ASU drugs
On December 21, 2018 the drug and cosmetics (Eleventh amendment) Rules 2018 notified vide gazette notification no. G.S.R. 1230(E) inserted new Rule 170 in Rules, introduced unique ID number system for Ayurvedic, Siddha and Unani (ASU) medications sold in the country, which provide a stringent regulatory check for misleading and inappropriate advertisements. As per the new notification, if the drug is not intended for therapeutic purpose, for instance a health or nutritional supplement, the manufacturer can advertise the product after obtaining a unique identification number (UIN) from state licensing authorities11.
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