The ASEAN network comprising of major countries in South East Asia including Indonesia, Philippines, Malaysia, Singapore, Thailand etc. are looking to harmonize their medical devices, drugs and in vitro diagnostics regulatory requirements to facilitate trade. Medical device regulatory consultants are hoping that India also joins this attempt to harmonize the regulatory requirements.
The Central Drugs Standard Control Organization (CDSCO) is the Indian regulatory body which regulates drugs, medical devices and cosmetics in India. For medical device distribution in India, several products require registration and come under the Notified medical devices. The other categories of medical devices can be directly imported into India. Medical device companies, drug manufacturers and cosmetic manufacturers have to have an Indian agent to liaison with the CDSCO. Morulaa HealthTech assists in obtaining registration approval for your medical device, drug and cosmetics in India. Morulaa keeps updated with the latest notifications of regulatory news by the CDSCO. Listed below are the achievements and initiatives taken by the CDSCO over the last one year:
- Strengthening of CDSCO
- Strengthening of state drug regulatory system under 12thfive year plan
- Drugs and cosmetics (amendment) bill
- Ranjit roy chaudhury expert committee for strengthening clinical trial regulations
- National survey on to assess the prevalence of spurious substandard drugs
- Revision of national list of essential medicines (NLEM), 2011 fixed dose combination
- Prohibition of testing of cosmetics on animals
- Restriction of sale of oxytocin bulk
- Banning of drugs
- Clinical trials
- Provision for labeling, standards etc for medical devices
- Signing of statement of intent between fda us and ministry of health and family welfare
- Visit of Indian delegation to Vietnam
1. Strengthening Of CDSCO
i. Manpower strengthening
From 111 in 2008 to 474 in 2014, the CDSCO is progressively strengthening its man-power to improve the efficiency of the regulatory organization. For medical device registration, drugs approvals and cosmetic approval independent officers and teams are in place to review the applications. Also, 250 contractual staff have been appointed to cope with the demands of medical device companies.
ii. Training and workshops
The CDSCO has conducted 36 training programs and work shops in 2014 for improving the skills of the concerned officers to deal with the review of the applications and with the Indian agents of medical device companies, drug companies and regulatory consultants.
iii. 12th Five Year Plan
The revised outlay under 12th Five Year Plan for strengthening of Central Drug Regulatory System provides an outlay of Rs. 900 crores for strengthening of infrastructure of Indian regulatory body – CDSCO.
iv. Strengthening of Central Drug Testing Laboratories
For strengthening the testing capacities of the Central Drug Testing Laboratories, the sanctioned amount of 12,84,77,206/- has already been spent on account of procurement of various equipments for these laboratories.
2. Strengthening Of State Drug Regulatory System Under 12thFive Year Plan
The CDSCO would provide financial and human resource support to the state drug and medical device authorities in a sharing pattern of 75:25. The focus of the sharing relationship is for upgrading state labs, expanding existing offices, manpower increase and creation of mobile labs. Each state is expected to set aside Rs. 229 crores for this purpose, with the CDSCO providing Rs. 850 crores.
3. Drugs And Cosmetics (Amendment) Bill
The Drugs and Cosmetics (Amendment) Bill, 2013 to amend the Drugs and Cosmetics Act, 1940 include separate chapters for clinical trials and regulatory approval of medical devices. The draft Bill has been uploaded by the Ministry of Health and Family Welfare on its website for comments from the public. The Bill will then be placed before the cabinet for introduction in the Parliament.
4. Ranjit Roy Chaudhury Expert Committee For Strengthening Clinical Trial Regulations
The Expert Committee constituted by the Ministry of Health and Family Welfare under the Chairmanship of Prof. Ranjit Roy Chaudhury had made a number of recommendations in respect of regulating the conduct of clinical trials in the country in a most authentic and transparent way. The key recommendations include use of information technology for transparency, establish a system of reporting adverse effects, compensation to clinical trial patients and ensuring systems for authentic data generation from trials.
5. National Survey On To Assess The Prevalence Of Spurious Substandard Drugs
42,000 samples have been collected from all over India to assess the quality of drugs manufactured in India. This study is conducted by State Drug Inspectors who are trained by the National Institute of Biologicals, Noida.
6. Revision Of National List Of Essential Medicines (Nlem), 2011
The National list of essential medicines (NLEM) is one of the key instruments in balanced healthcare delivery system of a country which inter alia includes accessible, affordable quality medicine at all the primary, secondary, tertiary levels of healthcare. NLEM was last revised in 2011.
Fixed Dose Combination
10 Expert Committees were constituted on 03.02.2014 and have done extensive work to examine the FDCs and the report of these committees is expected shortly
7. Prohibition Of Testing Of Cosmetics On Animals
- The Drugs and Cosmetics Rules, 1945 has been amended via Gazette notification G.S.R. 346(E) dated 21.05.2014 prohibiting the testing of cosmetics on animals in the country.
- These rules were further amended to prohibit import of cosmetics tested on animals vide Gazette notification G.S.R. 718(E) dated 13.10.2014.
8. Restriction of Sale of Oxytocin Bulk
To curb the misuse of Oxytocin by dairy owners for extracting milk from milch animals, the Ministry of Health and Family Welfare issued a notification under Section 26A of the Drugs and Cosmetics Act vide G.S.R. 29(E) dated 17.01.2014 restricting the manufacture and sale of oxytocin as under:
- The manufacturers of bulk oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug.
- The formulations meant for veterinary use shall be sold to the veterinary hospitals only.
9. Banning Of Drugs
Following drugs were prohibited
- ‘Dextropropoxyphene and formulations containing Dextropropoxyphene for human use’ (G.R. 332(E) dated 23.05.2013).
- ‘Fixed dose combination of flupenthixol + Melitracen for human use’ (G.S.R. 377(E) dated 18.06.2013) and 498(E) dated 11.07.2014.
- Analgin and all formulations containing analgin for human use to be marketed for restricted indications only (GSR 86(E) dated 13.02.2014).
10. Clinical Trials
Various initiatives have been taken for further strengthening of clinical trial regulation to ensure the protection rights, safety and well being of Clinical Trial subjects and authenticity of bio medical data generated. Some of the initiatives are given below:-
- Compensation for ineffectiveness and placebo group trials, serious adverse events, case of injury or death during the clinical trials.
- A system of supervision of procedure for grant of clinical trial has been put in place.
- The procedure now followed for review of Clinical trial applications is a three tier review process. The applications are first evaluated by the New Drugs Advisory Committees, now renamed as Subject Expert Committees (SECs) / Investigational New Drugs (IND) committee. The recommendations of these committees are reviewed by the Technical Committee and then approved by the Apex Committee.
- It has been made mandatory that in all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject to be done.
- An Expert Committee has been constituted to examine the reports of deaths in clinical trials. The committee has prepared a formula for determining the quantum of compensation in case of clinical trial related deaths which is available in CDSCO website.
- An administrative order was issued by DCG(I) making it mandatory for the sponsor or his representative to furnish the detail of the contract entered by the sponsor with the investigator / institution with regard to finance support, fees, honorarium, payments in kind e to be paid to the investigator.
LEARN MORE: Documents required for Clinical Trials in India.
11. Provision For Labeling, Standards Etc For Medical Devices
The Drugs and Cosmetics Rules, 1945 were amended vide G.S.R. 690(E) dated 25.09.2014 for making provisions for the manner of labelling, qualification of competent persons to manufacture and test medical devices, shelf life, provision for standard to which these devices should adhere and exemptions for custom made devices for their import and manufacture.
12. Signing Of Statement Of Intent Between USA-FDA and Ministry Of Health And Family Welfare
The United States Food and Drug Administration (FDA) and the Ministry of Health and Family Welfare of the Republic of India sing a Statement of Intent to strengthened bilateral cooperation in the area of regulatory system of medical products to promote and protect public health on 10.02.2014.
13. Visit Of Indian Delegation To Vietnam
A team of CDSCO officials visited Drug Administration of Vietnam (DV), Vietnam in June, 2014 to have first hand information on the quality complaints in respect of drugs exported from India by Indian Pharmaceuticals Companies and suggest suitable remedies.
From medical equipment such as x-rays, scanners, ECGs, EEGs, diagnostic devices, patient monitoring systems, infusion systems, haemodynamic monitors etc. to medical devices such as stents, catheters, dental implants, wound healing, bandages, syrings, needles, sealants, etc. the CDSCO is attempting to streamline the approval process for the Indian medical device market.
