The Union ministry of Ayush will soon amend the Drugs and Cosmetics Rules, 1945 to prohibit misleading advertisements of Ayurveda, Siddha & Unani drugs.
Presently, there are no regulatory provisions for pre-censorship on advertisements. Action is taken whenever violation of Advertisement Code is brought to the notice of the Ministry of Information and Broadcasting or the advertisement is found to be in contravention of the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder.
In fact, the Ministry in consultation with Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) had already framed and notified draft rules for prohibition of misleading advertisements of Ayurveda, Siddha and Unani drugs in the Official Gazette vide GSR No. 396(E) dated 4th April, 2016 to amend the Drugs and Cosmetics Rules, 1945.
At present, complaints about the misleading content of the advertisements of ayurvedic medicines received in the Ministry of Ayush from any source are forwarded to the concerned State Licensing Authorities with the direction to take necessary action in accordance with the provisions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Drugs & Cosmetics Act, 1940 and Rules thereunder. In several cases, the state authorities have reported to have taken actions.
The ministry is now amending the law as it is aware of the sale and advertisement of ayurvedic medicines through TV channels which are required to adhere to the Advertising Code prescribed under the Cable TV Networks (Regulation) Act, 1995 and Rules framed thereunder.
At present, there are some mechanisms in place for quality control of products sold or promoted through advertisements. Ministry of Information and Broadcasting has constituted an Inter-Ministerial Committee to look into the violations of advertisement code suo-moto or whenever violations of the advertisement code are brought to the notice of the Ministry in respect of private TV channels. The Inter-Ministerial Committee meets periodically and recommends actions in respect of alleged violations reported. An advisory was also issued by the Ministry of Information and Broadcasting on 21.8.2014 advising all TV channels not to telecast advertisements which were found to be violating the provisions of Cable Television Networks Rules, 1994, Advertising Standards Council of India (ASCI) Code and also Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954.
As part of the self-regulatory initiative of the industry, Advertising Standards Council of India (ASCI), a voluntary body of advertisement industry, promotes self-regulation of advertisement content by monitoring and deciding on complaints against advertisements making misleading, false and unsubstantiated claims of the products including ayurvedic medicines.
In line with the functioning of the Drugs Technical Advisory Committee under the ministry of Ayush, a state level technical committee is recommended to be constituted in every state to advise on technical matters related to licensing and quality control of ASU drugs.
A proposal in this regard has been made by the Ayurveda, Siddha, Unani, Drugs Technical Advisory Board (ASUDTAB) in the draft rules framed by the ministry for the amendment of D&C Rules.
The draft rules to be inserted in the amendment of the Drugs and Cosmetics Rules, 2016 proposes that all the state governments must constitute a ‘State Technical Committee (STC- ASU) for Ayurveda, Siddha and Unani Drugs’ to advise the state government on technical matters related to licensing and quality control of ASU drugs.
In the draft notification issued by the ministry it is clearly mentioned that the committee should consist of experts with post graduate qualifications in either of the ASU category and one each from pharmaceutical chemistry, pharmacognosy, clinical pharmacology and ASU pharmacy.
Once the Committee comes into effect, the state licensing authority should consult the STC for licensing of all the drugs defined under Section 3 (a) of the D&C Act. As per the draft notification, the SLA has to dispose off the application of the manufacturer within two months from the date of submission with all required documents. The STC is constituted under Rule 152 A (6) of the D&C Rules. Further, it is proposed that the SLA should be supported by Drug Testing Lab accredited by the National Accreditation Board or a Laboratory approved under the Drugs and Cosmetics Rules, 1945.
After the amendment of the Rules, the certificate of renewal of a licence in Form 25D will be issued in Form 26D. The application for renewal should be accompanied with year wise detail of the quantity of drug manufactured (batch wise details) during the past three years (in case of first renewal of New Ayurvedic, Siddha or Unani drugs), or past five years (in case of renewal of licence of drugs described under section 3 (a) and section 3 (h) of the Act) along with a consolidated safety report listing side effects, fatalities, injuries etc. related to the drug.
Similarly, the certificate of renewal of a loan licence in Form 25E will be issued in Form 26E.
An original licence in Form 25D or a renewed licence in Form 26D, unless sooner suspended or cancelled, will be valid for a period of five years from the date of its issue or renewal. The original licence issued for drug defined under section 3 (h) for New Ayurvedic, Siddha or Unani drug will be valid for a period of three years from the date of its issue. The time limit of three months will be substituted by two months and fee of Rs.500 will be substituted by Rs.1000.
Prime Minister Narendra Modi launched the second International Yoga Day celebrations in Chandigarh on Tuesday. PM Modi addressed thousands of people gathered for asanas at Chandigarh’s Capitol Complex. Over 30, 000 people, including 100 differently-abled children, participated in the event, which began at 6.30am. The theme of this year’s event is to ‘Connect the Youth’.
Here are the highlights from the PM’s address on Yoga Day:
- Yoga talks about what you will get in this life. It is not a science of afterlife
- This is a day linked with good health and now it has become a people’s mass movement
- The way mobile phone has become a part of life, you can make yoga a part of your life too
- The UN is celebrating International Yoga Day all over the world. It was started last year on India’s request. This day was picked as it is the longest day and the Earth is closest to the Sun
- I really feel some people don’t fully understand the power and benefits of Yoga
- The world supported the idea of International Day of Yoga. All sections of society came together in this endeavour
- This is a day linked with good health and now it has become a people’s mass movement
- Yoga is not about what one will get, it is about what one can give up
- With zero budget, yoga provides health assurance. Yoga does not discriminate between rich and poor
- Important to integrate yoga with our lives. Do not wait, make yoga a part of your life
- Let’s make yoga more popular globally. Let India produce good yoga teachers
- Let’s focus on one thing in the coming days, how to mitigate diabetes through yoga. Diabetes can surely be controlled through yoga
- Today on the second International Yoga Day, on behalf of the Indian Govt, I am announcing 2 awards. Next year, on this day these awards will be given on behalf of India: (a) Best contribution to yoga internationally (b) Best contribution to yoga within India
Disclaimer: All photos of Honorable Prime Minister Mr. Narendra Modi ji participating in International Day of Yoga (21-Jun-16) has been sourced from the Official Twitter Account of Press Information Bureau (www.twitter.com/PIB_India)
As part of promoting and developing the traditional Siddha treatment system worldwide, especially among the Tamil diaspora, the Chennai-based Centre for Traditional Medicines and Research (CTMR) has made scores of proposals to the Sri Lankan government on Siddha system of treatment as part of implementing various health projects in the northern Tamil Province of the island nation.
The Minister for Health for Northern Province, Dr. P. Sathyalingam had recently invited the director of CTMR Dr. T. Thirunarayanan to Sri Lanka to explain in detail the proposals he made to the Lankan government to strengthen the system there. The proposal sought support from the Indian government as well as the state government of Tamil Nadu. In the meeting, he discussed with various health officials, medical officers and hospital authorities who are following the traditional system of treatment there.
While sharing details about his visit to Sri Lanka, Dr Thirunarayanan said manufacture and supply of traditional drugs, especially Siddha medicines, is always a difficult problem there, and there occurs a long gap in the supply system. The quantum of medicines manufactured is very less and often inadequate to cater to the needs of the patients.
In a proposal to develop production and marketing of Siddha drugs, CTMR has suggested that maintenance of quality standard is of prime importance, and for that there should be a testing methodology which should be followed in the analytical process. A well equipped laboratory is essential to address issues like adulteration, misbranding, spurious, not-of-standard quality, etc. Besides, government should ensure availability of good raw materials.
To increase the availability of Siddha medicine in the island country, Dr. Thirunarayanan made a major suggestion that a government owned manufacturing unit with state-of-the-art facilities should be set up. The facilities should be in compliance with WHO-GMP standards. For the availability of raw drugs including herbs, medicinal plants, the government was advised to encourage founding herbal gardens at schools, colleges, homes, public parks, etc and planting of medicinal saplings as much as possible everywhere involving NGOs.
Further, he suggested to digitize the palm leaf manuscripts of Siddha available with traditional healers there and also with the libraries. CTMR will give training in the digitization of palm leaves. He said the government of Sri Lanka can approach the ministry of Ayush in India through ministry of external affairs for financial assistance to train the graduates in Siddha and to conduct continuous medical education programmes and skill development schemes.
For strengthening the potential and skill of traditional medicine practitioners in Sri Lanka, he said the Siddha practitioners in the Northern Province have to undergone specialized training in various treatment methods of Siddha like Varmam, Thokkanam, Kayakalpam, Balar maruthuvam, skin diseases, non-communicable diseases and mental health.
Source : Pharmabiz
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