THD NewsDesk, New Delhi: The Modi government has approved three more drugs prohibited by the Indian government’s first eradication on a fixed-dose combination (FDC’s) or “drug cocktails” in 2007.
On September 8, the decision was delivered by Drug Controller General of India (DCGI), V.G. Somani. He also heads India’s apex medicine watchdog CDSCO. Through a letter did he confirm to all the State-Level Drug Authorities and the Union Health Ministry.
Somani stated in a letter that, “As per the DTAB (Drugs Technical Advisory Board, a high-level government panel) dated July 29, there are three more FDCs which have been considered as rational under the 294 FDCs category.”
A drug is characterized as “rational” when a combination drug is certified to have a benefit over a single compound drug.
Including these, 86 FDCs from the 2007 list of 294 cocktail drugs are now passed. The three FDCs consist of a hypertension drug (Losartan + Atenolol + Hydrochlorothiazide). Another medicine for neuropathic pain (Duloxetine + Methylcobalamin). Lastly, for nutritional deficiencies (Methylcobalamin + Vitamin B6 + Folic Acid Uses).
FDC integrates more than one drug in a single pill. The plan is to mitigate docility for compelled patients to take multiple medicines as a part of long-term medication. It is also composed when the combination is proven to have a definite advantage over single-compound drugs.
These drugs were under surveillance because a lax regulatory framework approved several unscientific combinations to surplus the market. There is an anxiety that “they may increase drug resistance.”
There have been many drugs that have outlawed due to the government fizzling out. These three drugs were banned in the first round, 13 years ago. Now many those drugs that were prohibited in 2007 remain sub judice. Many manufacturers are challenging the ban as these three got a clean chit. Top manufacturers include Sun Pharma, Wockhardt, and Torrent Pharma.
On November 28, 2007, the ban was termed not only crucial but also controversial. Many perturbed drugmakers “managed to get a stay from the Madras High court.” The case is still waiting in the Supreme Court and is moved to the Central Government’s instance.
Nevertheless, the three fresh permissions came amid a muted response to the authorization given to 83 other drugs on the list.
On February 27, 2019, the DCGI issued a detailed procedure for manufacturers to follow for obtaining permission. August last year’s targeted date was but got rescheduled to March 31, 2021, with a deterring of no more delays by the government.
Somani noticed the solicitudes about there being “no mention of strength and dosage forms in the list” issued by the DCGI. He then explained that authorization would be based on the “(same) dosage form and strength licensed before November 28 2007.”
The drugmakers’ lukewarm response was due to the high-priced application per drug combination and variations in drugmakers’ product portfolio over the past decade. The current clinical trial jurisdictions released in March 2019, the government raised the application fees for manufacturing approval to Rs 2,00,000 per FDC from Rs 15,000 per FDC.
A senior official representing drugmakers said, “If I need approval for 10 FDCs from the list of 86 approved drug combos, I need Rs 20 lakh. Many companies don’t want to spend money on these controversial combos, right now.” He further stated, “Moreover, as the matter remained in court for years, several drugmakers have already tweaked or discontinued their products.”