Re: [india-drug] Combination drugs set to lose licences in India (2)

["Dr. Thatte" <mthatte@vsnl.com>]

Combination drugs set to lose licences in India (2)
******************************************************

Dear all,
I join this discussion as a practising surgeon to draw your attention to 
another pernicious practice: Brand name suffix with different molecules. As an example there are several Parenteral antibiotics with a given name say XYZ, the same company then promotes anothher molecule as XYZ-O which is often a completely different molecule with a different antimicrobial 
spectrum. Gullible house surgeons write that one on discharge assuming it to be the oral form of the IV  antibiotic--often resulting in wrong treatment as the microbe concerned is not even officially covered---that the doctor ought not to go by the name is accepted but even then this practice of branding is dangerous and ought to be strongly discouraged. I would be keen to know your views on this.

Warm Regards,
Mukund Thatte
Consultant Plastic and Hand Surgeon
"Dr. Thatte" <mthatte@vsnl.com>
----- Original Message ----- 
From: "Sampada Patvardhan" <dicmspc@yahoo.co.in>
To: "Leela McCullough" <leela@healthnet.org>; <india-drug@healthnet.org>
Sent: Saturday, September 01, 2007 9:59 AM
Subject: [india-drug] Combination drugs set to lose licences in India (1)


Combination drugs set to lose licences in India (1)
*******************************************************

  State drug control departments to be told to withdraw approvals for 3,000 
brands over safety, efficacy worries
      (Please visit: 
http://www.livemint.com/2007/08/19235926/Combination-drugs-set-to-lose.html)



        New Delhi / Mumbai: India's drug regulator is set to ask state drug 
control departments to withdraw approvals for 3,000 brands of so-called 
"combination drugs", which generate nearly Rs4,000 crore in annual revenues 
for dozens of drug companies but whose efficacy and safety are in question.
  The move comes after years of discussions and deliberations over the 
pending proposal. The drugs in question are manufactured and marketed by 
almost all of India's leading drug makers.
  FACING THE AXE (Graphic)
  The move to pull the drugs from the market is on the ground that they were 
not approved by the central authority, because of which no regulatory 
formalities to prove their safety and efficacy were conducted, as is the 
requirement for all new drug approvals.
  The Central Drugs Standard Control Organisation, the central authority 
that approves new drugs for marketing in the country, will soon send notices 
to all state drug control departments asking them to withdraw licences for 
manufacturing these combination drugs.
  The office of the Drug Controller General of India (DGCI) has prepared a 
list of 282 such drug combinations, known in the industry as fixed-dose 
combinations. These combinations, made by combining one key drug with one or 
more other drugs, are available throughout the country in hundreds of drug 
brands.
  The fixed-dose combinations are made under the pretext of combining 
different drugs, which are already approved in India individually, into a 
single pill or capsule for treating multiple indications (diseases) in 
patients.
  "Though these drugs are individually approved here, a combined formulation 
has to be treated as a new drug and the safety and efficacy tests have to be 
conducted again to clear them for marketing. This is not done when the 
licences are sought from the state departments," M. Venkateswarlu, DGCI, 
told Mint.
  "We have already sensitized the issue in the Drug Consultative Committee, 
an advisory board to the central drug department that comprises of senior 
regulatory officials, drug experts and the state drug controllers," he said. 
"A list of these drug combinations has also been circulated to the state 
drug commissioners for their immediate attention."
  According to a senior member in the drug consultative committee who did 
not want to be identified, the list circulated to the states by the central 
department includes 37 brands sold by Cipla Ltd and Alkem Laboratories Ltd, 
36 brands of Nicholas Piramal India Ltd, 21 of the antibiotics leader Lupin 
Ltd, 12 brands of the Mumbai-based Sun Pharmaceuticals Industries Ltd and 
Wockardt Ltd, 15 brands of the country's largest drug maker Ranbaxy 
Laboratories Ltd and 30 brands of Ahmedabad-based Cadila Healthcare Ltd.
  Other drug makers included in the list are Emcure Pharmaceuticals Ltd (30 
brands), Ind-Swift Laboratories Ltd (40 brands), Mankind Pharmaceuticals Ltd 
(45 brands), Intas Pharmaceutical Ltd (30 brands), Blue Cross Laboratories 
Ltd (15 brands), Elder Pharmaceuticals Ltd (15 brands) and Cadila 
Pharmaceuticals Ltd (28 brands).
  "All these brands have been manufactured and marketed with licences 
obtained from state drug controllers in the last few years. If these states 
do not come out with an immediate action to review the licences, the central 
department will be forced to stop circulation of these drugs by using its 
judiciary provisions," said the drug controller general.
  Said Gujarat's commissioner, food and drug control administration, Subodh 
P. Adeshara: "We have not received any specific instruction from the central 
department to withdraw the licences so far. We are awaiting certain 
direction in this regard as states do not have powers to ban products, which 
are licenced from other states."
  According to Adeshara, Gujarat has never issued licences to any such 
first-time combinations.
  "At the same time, such products are already available in the state, which 
are licenced by other states. So, denial of licences to such products to the 
manufacturers in Gujarat will be an injustice. Hence, we have issued 
licences and had also immediately alerted the central department about the 
same," Adeshara said.
  Industry experts said companies use fixed-dose combinations for two 
reasons, the most important being to override the Drug Price Control Order 
by adding one or two drugs with a drug on which the National Pharmaceutical 
Pricing Authority (NPPA) fixes a price ceiling.
  The second reason is higher margins as drug makers can charge more for the 
combination even as the packaging and distribution cost typically remain 
that of a single drug.
  Swati Piramal, director, strategic alliances, Nicholas Piramal, maintains 
that Indian companies have developed combinations in response to the needs 
of the medical community. "Doctors have often complained that patient 
compliance is a huge issue," she said. "We have to understand the realities 
of treating chronic illnesses where patients have to take too many pills and 
usually end up not taking some of them, causing more harm."
  According to her, Indian companies can lead the way in proving to the 
world that in some cases combinations work well and could provide an 
alternative to some of the compliance issues that plague medical management 
today.
  Most of the drug makers who are active in this market segment and 
contacted by Mint declined to comment on the regulator's move.
  As per current drug regulatory system in India, any new drug to be 
launched in the country has to be approved by DGCI. At the time of new drug 
approval, the central department requires detailed safety and efficacy data 
submitted by the drug maker after completing the mandatory clinical trials, 
bio-equivalence and bioavailability studies. Following this, the state drug 
control departments issue manufacturing licences for those drugs.
  However, the states can issue manufacturing licences to any drug after 
four years of its first approval in the country without a mandatory 
clearance from the drug controller no matter where such drugs are sold. 
Since the state drug controllers are appointed by respective state 
governments, the drug controller has no direct power to take penal actions 
against the state departments for any alleged wrongdoing.
  "This is the key reason for introducing a single licensing body for drugs 
in the country by setting up the proposed Central Drug Authority," says 
Venkateswarlu.
  Says Chandra Gulhati, editor of MIMS India, a drug reference index for 
physicians: "The fixed-dose combination problem finds its genesis in the 
government's move to promote the small-scale industry in the 1970s. While it 
was fine to promote the growth of small-scale industries for other sectors, 
extending those benefits to the pharmaceutical industry has been 
disastrous," says Dr Gulhati, who has been spearheading the cause of banning 
these drugs saying that no other country has these drugs.
  "If DCGI is serious and implements this, it will wipe out many of the 
small sector companies that survived purely on marketing these drugs."
  Sampada Patvardhan, director of drug information centre, Maharashtra State 
Pharmacy Council, believes it is possible for fixed-dose combinations to be 
created in such a way that it will not be harmful and may be even more 
beneficial than the individual drugs.
  "The Indian drug industry is quite advanced in its formulation 
technology," says Dr Patvardhan. "It can develop combinations using certain 
coatings to enable them to be different entities within a single 
formulation."
  "Many irrational fixed-dose combinations have been around in the Indian 
market for a while now," adds Urmila Thatte, head, department of clinical 
pharmacology at BYL Nair Hospital and Research Centre in Mumbai. "In 
principle, most drugs should not be put in combinations because this could 
create more problems than they could solve. The drugs may interact with each 
other, or may interact with food. They may even cause adverse reactions and 
a physician may find it impossible to identify which drug has caused it."
  "Implementation of rules targeting irrational fixed-dose combinations may 
be a little tricky now as health is a state subject," adds Dr Thatte. "The 
authorities at the Centre will have to ensure that all states agree to 
tackle the issue and also actually implement the rules. Also, it is not fair 
to tar all combinations with the same brush. In some cases, combinations may 
not be harmful and may even be desirable-such as anti-TB drugs, where 
patient compliance is improved, or oral contraceptives, where a combination 
works better than a single drug."
  (ch.unni@livemint.com)

    forwarded by:
  Dr. (Mrs.) Sampada Patvardhan (Ph.D.Tech.)
  Director, Maharashtra State Pharmacy Council's Drug Information Centre
  Email: dicmspc@gmail.com















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