Govt plans to set up body to regulate medical devices sector

Source: Business Standard, Sept 26, 2019

New Delhi: The government is planning to set up a Medical Devices Authority (MDA) for the entire spectrum in the medical devices sector — gauges, weighing machines, orthopaedic implants or whatever.

It will, however, not have powers on pricing. That will continue to be vested with National Pharmaceutical Pricing Authority (NPPA), senior officials said.

The proposed body will be separate from the Central Drugs Control Standard Organisation (CDSCO), which will continue to be the regulator for drugs.

The Bureau of Indian Standards (BIS) will still frame guidelines but these would be regulated by MDA. The arrangement would be on the lines of food items, where BIS designs the standards but these are enforced by the Food Safety and Standards Authority of India. Read the rest of this entry »

A year on, Ayushman Bharat faces multiple challenges ahead

Source: The Hindu Business Line, Sept 24, 2019

New Delhi: The free cashless health insurance scheme for the poor, Pradhan Mantri Jan Arogya Yojana (PM-JAY) or Ayushman Bharat completed a year on September 23. The National Health Authority (NHA) which implements the scheme stated that 46.4 lakh had received treatment through hospitalisation under the scheme. However, the past year has thrown up multiple challenges for the plan.

One such challenge is to strengthen its fraud control mechanisms. NHA said in its press release that patients availed free treatment worth nearly ₹7,500 crore . This means that the average cost of treatment per patient in the scheme comes up to ₹16, 164. The average promised annual cover of five lakh rupees per family is way higher than the average cost of treatment of a patient, considering that it is highly unlikely that all family members will avail the benefit in the same year. Read the rest of this entry »

Serum Institute opens world’s largest vaccine facility

Source: Financial Express, Sept 10, 2019

Pune: Serum Institute of India (SII) has opened the world’s largest vaccine manufacturing facility with an investment of Rs 3,000 crore in a capacity expansion move aimed at capturing 10-15% share of the international market.

The institute is getting ready to export Made in India vaccines to regulated markets like Europe and the US from its new facility, which will produce half-a-billion doses annually. Spread across 2 million sqft, the facility will cater to 150 countries.

The new multifunctional production facility for vaccines at the Poonawalla Bio-Tech Park at Manjri was inaugurated by Union minister for health and family welfare Harsh Vardhan on Monday. Read the rest of this entry »

Govt to regulate four more medical devices

Source: The Hindu Business Line, Dec 11, 2018

New Delhi: Four more medical devices — nebulisers, glucometers, digital thermometers and blood pressure monitors — have been notified in the latest addition to product categories under the Drugs and Cosmetics Act, which will ensure their quality and performance.

This means such devices will be under regulation and their import, manufacture and sale will be under scrutiny. Twenty-seven product categories are now notified under the Act, said an official from the Ministry of Health and Family Welfare (MoHFW). The categories which are not notified for regulation are sold in the open market without adequate checks and balances, including for instance, pacemakers. “We are moving in the direction to now regulate all implantable devices,” said S Eswara Reddy, Drug Controller General of India (DCGI). Read the rest of this entry »

Govt issues new guidelines for foreigners seeking organ transplant in India

Source: Business Standard, Nov 22, 2018

New Delhi: The Health Ministry has made it mandatory for foreign nationals seeking organ transplant in India to be registered in the waiting list of hospitals following reports claiming they were being given preferential treatment by some private institutions.

The registered transplant centre has to intimate the Regional Organ and Tissue Transplant Organisations (ROTTOs) and the list of foreign nationals seeking organ donation in India has to be shared with the NOTTO (National Organ and Tissue Transplant Organisation) in advance, officials said here.

Also, an organ can be allotted to a foreign national only if there is no Indian recipient available to receive the donated organ at that time, said Dr Vasanthi Ramesh, Director of NOTTO.

Among the patients from abroad, NRIs and persons of Indian origin will be given preference. Read the rest of this entry »

Govt set to bar homeopathy doctors from selling drugs

Source: LiveMint.com, Oct 10, 2017

New Delhi: Homeopathy doctors will soon be barred from selling medicines from the premises they are practising in, according to new rules proposed by the government that are to be notified soon.

“No registered homeopathic medical practitioner who is practicing homeopathy in the premises where homeopathy medicines are sold, shall deal in homeopathic medicines,” according to the new draft rules.The new rules were drafted following complaints that commercial interests were influencing the behaviour of homeopaths, two government officials privy to the development said.

“It was seen that various pharmacists had started to station a homeopath in their shop for consultations. Likewise, homeopathy practitioners other than dispensing their medicines to their patients had started selling them over the counter too. For better regulation of homeopathic medicines, this practice needed to end,” said one of the two officials cited above.

“Once notified, this will delink consultation and selling of medicines. Chemist shop is a commercial entity and the objective of this rule is to ensure that doctors only prescribe and not sell medicines,” said the official cited above, requesting anonymity.

Homeopath Kalyan Banerjee said that the new draft rules will come as a setback to doctors selling drugs.

“This will create a lot of problems for those doctors who sell medicines over the counter too,” Banerjee said.According to one of the draft rules, chemists selling allopathic medicines will also be allowed to sell homeopathic medicines without the need to have a separate licence, as required now.

“These medicines shall be sold in the original sealed small quantity packing and they will have to be stored separately from allopathic drugs,” said the second of the two health ministry officials cited earlier.

The proposed rules also aim to weed out unqualified people from dispensing homeopathic medicines.

A person eligible to practice medicine with prescriptive rights should hold a degree in homeopathy from a recognized university or a degree in pharmacy from a recognized university or a bachelor’s degree with one year of experience in dealing with homeopathic medicines in the clinic of a registered homeopathic medical practitioner or with the holder of a licence in Form 20C or Form 20D (applications for retail are made under these forms) or diploma in homeopathic pharmacy or diploma in homeopathy and surgery.

R.K. Manchanda, co-chair of a sub-committee of the Drug Technical Advisory Board (DTAB) and the Director General of Central Council of Homeopathy (CCH), said the new rules will help promote quality homeopathic medicines.

“The competent authorities have been defined in the new rules for dispensing homeopathic drugs, thereby preventing a host of complications caused by wrong dispensing. The homeopathic medicines will be available widespread in chemists shops as there will be no need to have an additional licence to keep homeopathic medicines as required as per the existing rules. Once the new rules come into effect, the homeopathic medicines will be readily available even in far-flung areas.”

Homoeopathic medicines are covered under the provisions of Drugs and Cosmetic Act, 1940.

The new draft rules which were discussed in detail by the sub committee of DTAB before they were sent to law ministry for vetting will be notified by the ministry of health and family welfare.

To promote homeopathy, the new rules also do away with the need for a licence for exhibiting homeopathic drugs for promotional activities in any fair.

The manufacturers will also have to adhere to requirements of Good Manufacturing Practices (GMP) for obtaining a licence for manufacturing, which will remain valid for five years.

 

Healthcare Global to set up 12 new hospitals in 18 months

Source: The Economic Times, Aug 23, 2017

NEW DELHI: Healthcare Global Enterprises (HCG), a Bengaluru-based chain of specialised cancer care centres, plans to set up a dozen new hospitals over the next 18 months, the publicly traded company’s chairman, BS Ajai Kumar, said.

HCG plans to expand its network of cancer care centres to about 30 from 21 now, and will add a few more IVF clinics to its existing network, Kumar told ET.

HCG has a partnership with Kamini Rao, a leading medical practitioner in the field of assisted reproduction, to run IVF clinics under the brand name ‘Milann’. Read the rest of this entry »