New Delhi: The Narendra Modi government has constituted a high-level committee to “simplify and expedite” the drug approval process in India, ThePrint has learnt, as the country continues to fight the Covid-19 pandemic.
Comprising top drug and vaccine entrepreneurs of India and senior bureaucrats, the committee was set up by the Ministry of Health and Family Welfare as an urgent measure to reform the drug regulatory system in India.
“The issue of reforms in the drug regulatory system has been engaging the attention of the government of India for quite some time now,” said the health ministry order titled ‘Constitution of a committee for reforming the Drug Regulatory System in India’. It was issued on 11 May.
The committee will revamp the Central Drugs Standard Control Organization (CDSCO), an arm of the health ministry that heads the regulatory system of drugs and medical devices in India.
While the order, accessed by ThePrint, applauds the latest moves taken by the CDSCO following the pandemic — including the fast-track access to testing kits, vaccines, therapeutics, preventive treatments and diagnostics — it stresses the need for “comprehensive changes” to make the system more effective.
Also read: Govt asks pharma firms when remdesivir, the big hope against Covid, can be made in India
Committee to chalk out plan
On the committee are billionaire entrepreneurs Adar Poonawalla, CEO of Serum Institute of India, and Zydus Cadila’s Pankaj Patel, along with top officials from the Department of Pharmaceuticals, Indian Council of Medical Research (ICMR), Department of Biotechnology (DBT) and All India Institute of Medical Sciences (AIIMS).
The committee will be chaired by Rajesh Bhushan, Officer on Special Duty, Ministry of Health, while Joint Drug Controller of India Dr Eswara Reddy will assist the committee that will work on adopting global standards for drug and medical device regulation amid the ongoing pandemic.
The committee first met on 19 May for a formal introduction and setting the agenda. Its second meeting for more elaborate discussions is scheduled to take place Friday.
Also read: India’s ‘R’ value falls to 1.22, but active Covid-19 cases could reach 1 lakh by 30 May
How the committee will work
The ministry had ordered the committee to study previous reports by various committees on the working of the CDSCO, on clinical trials, and on whether the current qualification criteria for the department head — the Drugs Controller General of India — needs to be revised and also address recommendations suggested by these committees that were not unimplemented.
“The committee will submit its report within a period of one month from the date of its formation,” the 11 May ministry order said.
The ministry noted in the order that the “requisite procedural changes” which have been carried out by CDSCO “have worked quite well”, but added: “However, it is felt that comprehensive changes in the drug regulatory regime should be carried out to reflect global best practices as well as domestic requirements and to streamline the CDSCO to make it more effective.”
“…It has, therefore, been decided to constitute a committee for studying the current drug regulatory system and to submit recommendations for reforming the system to bring it in line with global standards and to deliver more efficiently,” it further stated.
Also read: Every scientific success is built on a history of failures, Covid-19’s cure could be too
Attempts are underway to synthesise /prepare drug-vaccine in diff nations for COVID 19.Till the one is ready we should ensure that the Corona virus
doesn’t spread from person to person by means like wearing masks/ maintain social distancing..etc
At the same time we should also concentrate on
keeping our body fit through healthy diet,doing exercises…Most important is Atleast develop body immunity specially through diet/food…Even consuming some edible herbs both in raw form/Prepared(Modified..baked/cooked..goes a long way in this regard.The herbs are available in the form of leaves,shoots,roots,stems,bulb -tubers,flowers…barks,nuts..most herbs are very powerful/strong in effective cure/soothening/relief. Of pain ,ailment…The herbs. Etc are used over thousands of years.So traditional/Native/homely remedies should be revived now in a big/innovative…. way..The herbs(most…)grow easily,available in most parts of India,the country being tropical.Some species are becoming rare/scarce and are facing threat of extinction(example -CEROPEGIA BULBOSA….),due to many reasons like neglect by man,-Deforestation,clearing of lands for agriculture,projects,urbanisation…Thank god,Still lot of vegetative propagation of lots of species is done by animals,birds…in many ways.So it is high time (fundamental Duty…of)the govt…various concerned Depts.,associations…SHG’s…step in seriously Atleast now to conserve , use these in the present crisis time.A few following herbs deserve attention.
(1)Herbarium JCB/Phyllanthus Amaras-Raw leaves(2)Opuntia/prickly pear cactus-fruit(3)Surinam cherry fruit(4)Decalepis Hamiltonii- raw root (5) Physallis Peruviana-berries(6)Sarco stemma-raw stem(7)Neem Giloye/Tinospora cordifolia-Raw leaves(8) Passiflora foetida-Raw fruit /unripen nut(9) Cordia dichotomy – berries(Now in India these trees are abloom with berries because of its bearing season-April,May(10) Canthium Parviflorum-berries(11) Ceropegia bulbosa-leaves & bulbs raw(12) Toddolia Asiatica-Raw leaves(13) Corulluma Umbellata -Raw stem only(not flower)(14)Vilva tree/eagle Marmelos-Raw leaves(15)Vinca Rosea pink -Raw leaves(16) Gymnema Sylvester-Raw leaves(17)Tooth ache plant-raw flower(18)Sandal wood tree berries/fruits
(19) Pursley leaves -Raw(20) Celosia leaves raw(21)Pappaya leaf raw very small quantity,even black or white seeds about 6 no’s(21)Orange peel.Pomegrant inner peel,(22)Tender. Raw leaves of mango,Jamoon,Guava, Drumstick, Bryophilm.Touch me not,….(22)Basil leaves raw(23)Flax seeds -dried powder mixed in water,even trees tender raw leaves,even tender flower raw(23) Amaranthus Veridies wild -Raw leaves(24)Raw tender bomboo shoots/leaves(25)Raw Banana stem/even it’s juice(26)raw Fabaceae nut/it’s powder raw ,even mixed in water(27)Raw leaves of Centella Asiatica (28)Long pepper -Raw leaves or its raw bean/ nut(29)Wild goose berry, Aloevera,(30) Mexican mint/Coleus Aromaticus-Raw leaves(31) Souropus Androgynous/Star goose berry/Katuk-Raw leaves(31) ScutiaCircumeissa/Flacourtia Indica- berries(32)Raw Tomato leaves(33) Alternanthera sessilius-Raw leaves(34) Mulberry-berries(35) Plactranthus Amboinicus/Indian borage-Raw leaves(36) Justicia Adhatoda-Raw leaves(37)Neem leaves,raw-Even it’s ripen/unripen berry raw.(38)
Chia seeds-raw(soaked)(39)Raw Brahmi leaves(40)Rana Phal-raw leaves…..many more such conventional/non conventional, but edible both raw or baked/cooked…are very crucial for keeping the body healthy/immune…only thing is their proper dosage..Some of the herbs are specially suited for (affect ) mouth,/throat…eg..Toddollia Asiatica,Long pepper, Amaranthus Veridies wild,Mexican mint,Basil,..Even the food/spices-Garlic,ginger,Turmeric,clove,Pepper …should be consumed Raw in such a way that the requisite quantity (Based on age….)is chewed for about 6-8 minutes,then slowly swallow ed bit by bit,(Not just swallowing in one go),-Even these are used-cooked.but not effective as raw.More & more research should also be taken up in this regard specially of using lots of herbs for diff ailments,& should be available easily to all,as it is reported more & more new types of viruses (mutated…)are going to hit the countries/people in near future.