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Industry seeks Health Ministry intervention on ban of diluted nitroglycerine solution to overcome shortage of life saving drugs

Shardul Nautiyal, Mumbai
Tuesday, January 27, 2015, 08:00 Hrs  [IST]

The pharmaceutical industry in the country has sought the intervention of the Union health ministry to grant a stay for at least two years on the ban imposed by the Petroleum and  Explosives Safety Organisation (PESO) on the production of Diluted Nitroglycerine Solution, in order to switch over to a modified formulation and hence overcome the shortage of life-saving drugs in the coming future.

The Indian Drug Manufacturers Association (IDMA) has written to the Health Ministry, Drug Controller General of India (DCGI) and Chief Controller of Explosives on this issue.  

As per the submission made by IDMA, directions issued by PESO may kindly be stayed for at least two years so that manufacturers can continue manufacturing with existing formulation and simultaneously complete the process to switch over to the modified formulation in the larger patient interest.  

This ban will lead to abrupt non-availability of the particular concentration of nitroglycerin thus creating shortage of life saving drugs. Nitroglycerin and Nitroglycerin formulations are considered drugs as defined under section 3(b) of the Drugs and Cosmetics Act, 1940 and it is used as a medicine for angina pectoris (ischemic heart disease). It is available in different dosage forms such as in tablets, ointment, solution for intravenous use, transdermal patches, or sprays administered sublingually.

Directions by PESO have been issued in the light of the fact that Diluted Nitroglycerine Solution falls in the category of explosive class 1.1 D. Possession, sale and use of Nitro-glycerin based explosives has therefore been prohibited in view of Gazette Notification no. GSR 59(E) dated 21 January, 2004, issued by the Department of Industrial Policy and Promotion (DIPP).

These directions have compelled the manufacturers of Nitroglycerin formulations to discontinue manufacturing of Nitroglycerin formulations as they are unable to procure diluted Nitroglycerin (more than 1 per cent w/v).

According to an industry official, "It is necessary to give a time frame of at least two years to the manufacturers for effecting changes in the formulation, complete the processes and obtain regulatory approval. The switch from existing formulation to the changed formulation cannot happen overnight. The process involves number of steps and the manufacturers will have to take care of prerequisites such as process validation, analytical method validation and stability study. The manufacturers will have to also obtain regulatory approval for the changed formulation. This entire activity normally takes 1 to 2 years."

The quantity specified for the ban is applicable on the production of Diluted Nitroglycerine Solution having more than 1 per cent w/v nitroglycerine in Alcohol or Propyline Glycol.

From time to time, DCGI has also approved various dosage forms of Nitroglycerin. In India, many pharma companies such as Neon Laboratories Ltd, Swiss Pharma Pvt Ltd, Troikaa Pharmaceuticals Ltd, VHB Sciences Ltd, Sun Pharmaceuticals Ltd, Samarth Pharma Pvt Ltd etc are manufacturing different formulations which contain Nitroglycerin.

Non-availability of the aforesaid API will compel the manufacturers to make changes in the formulation and for this purpose such manufacturers will have to switch either 1 per cent w/v in Alcohol/Propyline Glycol or else 10  per cent in lactose.

 

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