No exemption from price control be granted to Neon's local anesthetic FDC under DPCO 2013: NPPA committee

This came during the 97th meeting under the DPCO, 2013, held on 06th of May 2022 under the Chairmanship of Shri Kamlesh Kumar Pant , Chairman where the application filed by Neon Laboratories for exemption under Para 32 of DPCO 2013 for the formulation "FDC of Ropivacaine Hydrochloride IP eq. to anhydrous Ropivacaine Hydrochloride 7.5 mg plus Dextrose (Monohydrate) IP 80mg per ml Injection" was thoroughly discussed.

Ropivacaine Hydrochloride is an anilide and is a long-acting local anaesthetic. It is used to cause numbness or loss of feeling in patients before and during surgery or labour and delivery.

"The provisions of the Drugs (Prices Control) Order, 2013 shall not apply to, -

(i) a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970) (product patent) and not produced elsewhere, if developed through indigenous Research and Development, for a period of five years from the date of commencement of its commercial production in the country.

(ii) a manufacturer producing a new drug in the country by a new process developed through indigenous Research and Development and patented under the Indian Patent Act, 1970 (39 of 1970) (process patent) for a period of five years from the date of the commencement of its commercial production in the country.

(iii) a manufacturer producing a new drug involving a new delivery system developed through indigenous Research and Development for a period of five years from the date of its market approval in India:

Provided that the provision of this paragraph shall apply only when a document showing approval of such new drugs from DrugsController General (India) is produced before the Government."

Neon Laboratories also filed evidences in support of the application, which include:

a. Copy of the Patent certificate issued by the Patent Office, Government of India to Neon Laboratories for the invention entitled "HYPER BARI C INJECTION SOLUTION OF ROPIVACAINE HYDR OCHLORIDE AND PROCESS FOR PREPARATION THERE OF "[Patent No: 304 288, Da te of gra nt: 11.12.2018, Period of grant: 20 years from 13.07.2015]

b. Copy of the new drug approval given by Central Drugs Standard Control Organisation (CDSCO) dated 01.10.20 21 to Neon Laboratories for the formulation "FDC of Ropivacaine Hydrochloride IP eq. to anhydrous Ropivacaine Hydrochloride 7.5 mg + Dextrose (Monohydrate) IP 80mg per ml Injection".

In addition, The Authority further noted the Patent Office, Government of India Report titled "Report on Scope of Patent claims with respect to application filed by Neon laboratories ltd. for exemption under Para 32 of DPCO 2013 for drug formulation "FDC of Ropivacaine Hydrochloride IP eq. to anhydrous Ropivacaine Hydrochloride 7.5 mg + Dextrose (Monohydrate) IP 80 mg per ml Injection" sent vide e-mail dated 13.04.20 22.

The patent report noted the following,

• Formulation approved by CDSCO contains in each ml, 7.5 mg Ropivacaine Hydrochloride IP eq . to anhydrous Ro pivac aine Hydrochloride; 80 mg De xtrose (Monohydrate) IP; and Q.S. water for injection IP;

• Claims of granted Patent No. 304288 cover within the scope a formulation comprising 5 mg Ropivacaine Hy drochloride; 4-15% w/v Dextrose; base/acid (as stated in claim 1 above) to adjust pH between 3.5 to 6.0 and water as a vehicle (copy of g ranted claim s 1-8 is also enclosed).

• Amount of drug Ropivacaine Hydrochloride is different in both the formulations, i.e. one that is approved by CDSCO and other that is allowed in said granted patent

• What has been approved by CDSCO as a formulation (of 1 ml) containing 7.5 mg of Ropivacaine Hydrochloride is not within the scope of claim s of granted patent in terms of amount of drug Ropivacaine Hydrochloride, whereas the formulation also contains 80 mg of dextrose ,which is within the scope of granted patent

• Further, the formulation approved by CDSCO also differs in respect of base/acid included to adjust the pH between 3.5 to 6.0 as per claim 1 of granted patent, which is not mentioned in the approved formulation of CDSCO.

Th e Authority deliberated upon the matter in detail and observed that the Report of the Patent Office, Government of India has noted that

(i) the formulation containing 7.5 mg of Ropivacaine Hydrochloride, as approved by CDSCO is not within the scope of claims of granted patent in terms of amount of drug Ropivacaine Hydrochloride, and

(ii) the formulation approved by CDSCO also differs in respect of base/acid included to adjust the pH between 3.5 to 6.0 as per claim 1 of granted patent, which is not mentioned in the approved formulation of COSCO. Thus, as per the Report furnished by the Patent Office, the formulation "FDC of Ropivacaine Hydrochloride IP eq. to anhydrous Ropivacaine Hydrochloride 7.5 mg + Dextrose (Monohydrate) IP 80mg per ml Injection" of Neon Laboratories , as approved by CDSCO is not with in the scope of the Patent No. 304288 claimed by the company.

Accordingly, the authority stated,

"Hence, the Authority is of the opinion that the formulation "FDC of Ropivacaine Hydrochlorid e IP eq. to anhydrous Ropivacaine Hydrochloride 7.5 mg+ Dextrose (Monohydrate) IP 80mg per ml Injection" of Neon Laboratories is not qualified for exemption under Para 32 of DPCO 2013."

Finally, in view of the above, the Authority decided,

"No exemption be granted to Neon Laboratories under Para 32 of DPCO 2013 for their formulation "FDC of Ropivacaine Hydrochloride IP eq. to anhydrous Ropivacaine Hydrochlorid e 7 .5 mg + Dextrose (Monohydrate) IP 80mg per ml Injection" and the application be treated as closed."