LICENSE REQUIREMENT OF TRADING OF OXYGEN CYLINDER

INTRODUCTION

The availability of drugs and medicines is important in ensuring the good health of the Nation. However, the availability of drugs and medicines should be prevented to ensure that those goods are not abused or abused by people. Therefore, the government has set strict rules and regulations for the production and distribution of drugs and drugs in India. The regulation governing the manufacture and sale of drugs is provided by the Drugs and Cosmetics Act, 1940, and the laws enacted under it. Control for drug use from the category of non-flammable substances during manufacture, sale, distribution, and time transferred to a patient or consumer by a pharmacist at a retail store, hospital, or pharmacy. In 1964, Ayurvedic and Unani drugs were also incorporated under the Drugs and Cosmetics Act, 1940. However, some businesses may require different types of drug licenses based on their business.

Under the Drugs and Cosmetics Act, the regulation of the manufacture, sale, and distribution of drugs is primarily a concern of State authorities while the Central Authorities oversee the licensing of New Drugs, Clinical Trials in the country, setting drug policies, controlling imported drugs, integration of Drug Enforcement Services and of the Drug and Cosmetics Act. The Director of General Drugs in India is responsible for approving licenses for certain categories of drugs. The Central Government in exercising its powers under Sections 5 and 7 of the Act stated that the prescribed regulations namely the Gas Cylinder Rules, 2004 regulate the filling, ownership, transport, and importation of such gases. The purpose of these Regulations is to ensure the safety of the majority of persons involved in the filling, ownership, transport, and importation of such gases.

MANUFACTURING PRACTICE FOR MEDICAL GASES

The organization must be a manufacturer of Medical Gases namely Medical oxygen IP, Nitrous oxide IP, Medical carbon dioxide, IP and must have a valid production license issued from the state Drug Controller in terms of the 1940 Drugs and Cosmetics Act and regulate their under.

General requirements:

•   A medical gut building will be in place and measures in place to avoid the risk of pollution.

•   Production will be carried out under the watchful eye of skilled workers with the required qualifications and practical experience in relevant fields. 

•    The premises will be built, constructed, converted, and maintained to suit the production activities to allow for the production of medicines under hygienic conditions. They will comply with the provisions of the Factories Act, 1948. 

•     A production facility will be built to allow for better production without compromising logical sequence of operations.

CONDITIONS OF LICENSE FOR PHARMACIES FOR MEDICAL GASSES DISPENSING

In the line with and in addition to obligations and responsibilities listed, it is the responsibility of the License Holder and of the Managing Pharmacist to ensure that the following conditions are adhered to when receiving, storing, and dispensing medical oxygen cylinders:

1.    The room where the oxygen is used or stored should be strictly designated as a “No Smoking Area” and the door should be properly labeled with the following instructions:

• No access to unauthorized personnel

•  Keep door constantly locked

• Oxygen cylinders store

•  A green diamond sticker together with a hazard warning should be affixed to both the door of the stores and the designated cupboard where it is intended to keep the cylinders.

2.    All the staff involved in operating the oxygen equipment should be properly trained, including the provisions of written procedures. All pharmacists working in the pharmacy (including all locum pharmacists) must be trained in advice to be given to patients when dispensing medicinal oxygen.

3.    The equipment supplied to patients with the medicinal oxygen gas should be designed and constructed for use in line with the supplier's specifications. This also applies to its handling.

4.    The number of medical oxygen cylinders stored should be kept to the minimum necessary to ensure sufficient supply is available for patients' needs.

5.    Where spare cylinders need to be stored indoors, the number should be kept to a practical minimum, located in well-ventilated areas, but not in passageways, stairways, or emergency exits.

6.    Empty and full cylinders should be stored separately. They should be stored in such a way that prevents cylinders from accidental falls. They should not be stored in stacks or on each other.

7.    Transport and delivery should be done by suppliers using vehicles authorized for the type of cargo and should take also necessary precautionary measures. Cylinders should be handled appropriately.

8.    Responsibility for adequate Health and Safety provisions for employees is the responsibility of the company or the pharmacy wee domiciliary oxygen dispensation is provided.

9.    Copy of delivery note by the supplier and of an issue note to the patient should be kept on record by dispensing pharmacist and a copy of a valid manufacturing license of the supplier should also be kept.

10. Pharmacists should have access to the electronic records database of suppliers to verify the prescription and patient details.

11.     An effective dispensation register of patients and details of oxygen cylinder provided is kept to allow easy retrieval in view of a batch recall.

12.    Any customer complaints should be logged and forwarded to the manufacturer.

PESO TO ISSUE LICENSE TO THOSE WITH PROPER INFRASTRUCTURE AMID COVID-19 CRISES

The Central Drugs Standard Control Organization (CDSCO), the Government of India has allowed all industrial oxygen manufacturers to produce oxygen for medical use during the coronavirus crisis. Additional oxygen treatment is part of the COVID-19 patient's clinical management. Therefore, it is important for the Government to ensure the availability and availability of oxygen for use throughout the country. Keeping this in mind, the Government of India approved the production of additional oxygen for medical use to avoid any shortages during the outbreak. Production facilities with an industrial oxygen base must be licensed for medical oxygen production and within 24 hours of receipt of the application, fees, etc. In terms of the Drugs and Cosmetics Act, 1940 and the Laws. The CDSCO has also instructed the Petroleum and Explosives Safety Organization (PESO), Nagpur, to take action in this regard in the community by granting a license to manufacture medical oxygen during the COVID-19 crisis. Similarly, the Government of India has emphasized that adequate storage of oxygen cylinders for therapeutic purposes should be maintained. The Secretary of the Department of Industry and Internal Trade led a meeting with PESO and key gas producers and oxygen cylinder suppliers to discuss issues to keep the supply chain flowing recently in the wake of the COVID-19 outbreak. From discussions with gas supply agencies and oxygen cylinder suppliers, it is understood that so far no shortages have been reported from any part of the country and that there have been no problems with the loading and transport of oxygen cylinders.

CONCLUSION

In India, CDSCO monitors the production and use of medical gases. The regulatory authority emphasizes appropriate coding, labeling, warning, and container safety procedures to facilitate the identification and avoid mixing. They also emphasize that the management of these gases should be done by a qualified professional only. India has incorporated medical gases and containers into its monographs to meet certain national standards. Despite all the control by the authorities there are still reports of disasters due to improper gas production around the world. There can be many unwritten cases worldwide especially in third world countries where there are weak regulatory systems and poor documentation practices. Each country has a law that guarantees safety, but the question is how rational it is being used. In India's best health care system there should be some guidelines and guidelines for medical gases to being prescribed and used.

eStartIndia will help you with getting the necessary approval for trading and manufacturing Oxygen Cylinder. Get Free Expert Advice with a simple registration with us!

Author:

eStartIndia Team