Pharmaceutical sector comprises of drugs and cosmetics. The whole medical sector is covered under the pharmaceutical sector. The medical sector requires changes with effect to the time, as we all have witnessed recently when the Covid 19 outbreaks. In the Covid time period a lot of changes were made in the pharmaceutical as and when required. The Government is taking initiative to uplift the pharmaceutical industry to provide best medical assistance to the society at large. Some of the key developments are highlighted in this article.
Drugs and Cosmetic (Amendment) Rules, 2020 (DC Rules):
The Ministry of Health and Family Welfare (hereinafter referred as MOHFW) notifies the DC rules which came into effect from March, 2021.
- In the DC Rules, the definition of word Marketer is added, and it is defines as “a person who as an agent or in any other capacity, adopts any drugs manufactured by the other manufacturer under an agreement for marketing of such drug by labelling or affixing his name on the label of the drug for its sale and its distribution.” Moreover it is clearly stated that the marketer shall be held responsible for quality of that product and the regulatory compliances, along with the manufacturer of the drug.
- If the drug is marketed by the marketer not being the manufacturer, apart from the prescribed information in the principal law, name and address of the marketer should also be printed on the label in a conspicuous manner in the innermost label of the drug.
Drug Delivery Notification:
The MOHFW issued notification on 26th March 2020 that now retailer can deliver medicine on door steps to the consumers. The notification provides the delivery of drug mentioned in schedule H, H1, X (other than the narcotics defined under the Narcotics Acts) mentioned in the Drugs and Cosmetic Act, 1945.
The validity of prescription for chronic disease is 2 months and for acute disease 7 days.
Medical Device Rules (Amendment in 2020):
The Central Drugs Standard Control Organization (hereinafter referred as CDSCO) publishes two amendments in the medical device rules which came into force on April 1, 2020. The two amendments are as follows:
- In the first amendment the definition of medical device is enhanced and the definition under clause 3 (b) (iv) of the Medical Device (Amendment) Rules, 2020 are as follows:
“All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
- Diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
- Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
- Investigation, replacement or modification or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- Disinfection of medical devices; and
- Control of conception.
- The second amendment of the medical device rule added chapter 3 A in the rules which says that all the devices in the Clause 3 (b) (iv) should be added in the list except the devices notified under schedule 8 of the rules. The changes should be made according to the newly added provision from 19 A to 19 F.
The striking features of the amendment are explained below: –
- The medical device should be voluntarily registered for 18 months after that it should be made mandatory.
- The information should be uploaded on the portal by the manufacturer regarding the medical device in respect of manufacturing entity, certificate of compliance with respect to ISO 13485 and the duly signed undertaking that the information provided by him is true and authentic.
- Those who import medical device shall furnish the free sale certificate from the country of origin as per the provisions specified under Rule 19 (D) (2) (ii) of the Medical Device Rules.
- After uploading all the information on the online portal, the manufacturer needs to print registration number on the label of device.
- The Central Licensing Authority may verify the quality and procedure at any time and the procedure of non compliance is also provided by the amendment rules.
Drugs (Price Control) Order 2013:
This order enables the Government to fix minimum or ceiling price of drug in an extraordinary situation for the interest of public as it deems fit notwithstanding the wholesale price index. The price of oxygen is fixed since 2016 but due to increase in the demand of oxygen during the Covid time period the prices of oxygen are revised (Revised Price Cap). The period is further extended till December 31, 2022 or until further ordered whichever is earlier.
Permit to import of drugs:
The CDSCO has extended its previous order to import the drugs having shelf life less than 60%. The extension is granted till October 31, 2022 or further orders whichever is earlier.
Upcoming legislation for Pharmaceutical Sector
Proposed Amendment to the Schedule K of the Drugs and Cosmetic Rules, 1945:
The MOHFW has proposed an amendment to schedule K of the aforesaid Rules which grants exemption to certain kinds of drug from obtaining the sale license. The exemption grants permission to sell the certain class of drugs over the counter without the prescription of registered medical practitioner. However the doses sold can’t be sold for more than the 5 day doses. The sale for more than the prescribed quantity is still prohibited without the prescription of registered medical practitioner.
Some of the listed drugs are Antifungal, Analgesics, Decongestants, and Laxatives etc.
Inclusion of QR code (Quick Response Code) in API (Active Pharmaceutical Ingredient) Labelling:
The MOHFW has issued the notification that a QR in API should be inserted on the labels of manufactured and imported goods in India. This amendment will come in effect from 1st January, 2023.
The QR code should label at packaging level to store data or information with a well managed software application to facilitate tracking and tracing of the product. The QR code must include the name of API, unique product identification code, brand name; batch no, batch size, date of manufacturing, date of expiry etc. It will help tracking and tracing of goods and would collect all the information in one place for easy access.
The government of India has made various changes in the laws for pharmaceutical industry and trying to make India self dependant in the medical sector. The initiative has been taken to make things easily provided by introducing new factors in the digital form such as adding of QR code, Drug delivery notification, Telemedicine etc.
Associate at Aggarwals and Associates, S.A.S. Nagar, Mohali